Device Dossier
Catheter tunneller single use
Device Dossier for Catheter tunneller single use (Catheter tunneller single use, Class IIb, sponsor New MedTek Devices). ARTG record, intended purpose,…
- GMDN category: Catheter tunneller single use
Intended purpose
The RrhoidCath Surgical Kit is intended for tunnelling catheters for infusion of pain medication close to the branches of the pudendal nerves at the time of haemorrhoidectomy. The pain medication is not included in the surgical kit and is administered at the discretion of the treating physician. To accurately locate the pudendal nerve branches, the Surgical Kit includes a nerve stimulation probe/trocar. The nerve stimulator probe is connected to a commercially available nerve stimulating device (not included in the Surgical Kit). When the nerve stimulator probe/ trocar delivering an electrical current not exceeding 5 mA is getting close to the pudendal nerve branches the psilateral external sphincter starts to contract. Infusion catheters are then placed in proximity to the nerve branches, ready to be connected to an infusion pump (not included in the Surgical Kit) for delivery of local anaesthetic. The infusion catheters are tunnelled from the ischiorectal fossae to the right hip region and secured in place at the exit site over the patient’s right hip by a strain relief device, to prevent catheter dislodgement for the duration of infusion as determined by the surgeon for individual patients, but not exceeding 7 days.