InjuryMZY
TUNNELING TOOL
Received Aug 12, 2023
Report MW5131709 · MDR key 17524765
Device
Generic name
Graft, Vascular, Stainless Steel Tunneler
Manufacturer
Inspire Medical SystemProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Hemorrhage/Blood Loss/Bleeding
- Perforation
- Hemorrhage/Blood Loss/Bleeding
- Perforation
Narrative
Description of Event or Problem
CALLER REPORTS TUNNELING TOOL WAS USED TO IMPLANT INSPIRE DEVICE AND DURING PROCEDURE PATIENT'S EXTERNAL JUGULAR VEIN WAS PIERCED. THE BLEEDING WAS CONTROLLER THROUGH LIGATING ABOVE AND BELOW WHERE THE LEAD WAS TUNNELED AND THE REST OF THE PROCEDURE WAS UNEVENTFUL. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).