VSI MICRO-INTRODUCER KITS
Report
- Report Number
- 2134812-2023-00058
- Event Type
- Malfunction
- Date Received
- December 15, 2023
- Date of Event
- November 14, 2023
- Report Date
- November 20, 2023
- Manufacturer
- VASCULAR SOLUTIONS LLC
- Product Code
- DYB
- UDI-DI
- 10841156102913
- PMA / PMN Number
- K180913
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(4).
(B)(4). NO PRODUCT WAS RETURNED TO TELEFLEX FOR INVESTIGATION. THE TOP-LEVEL ASSEMBLY TRAVELLER (RT104672, LOT 702288) WAS REVIEWED. THERE ARE NO DDA'S, NCE'S OR ANY OTHER NONCONFORMANCES RELATED TO THIS LOT THEREFORE SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. CASE DETAILS WERE REVIEWED. CUSTOMER STATED "BROKEN MIK AT THE HUB". THE ACCESS SITE WAS REPORTED AS FEMORAL IN THE ADDITIONAL INFORMATION. NO INFORMATION ON VESSEL FACTORS SUCH AS SCAR TISSUE, TORTUOSITY AND CALCIFICATION WERE PROVIDED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. A MANUFACTURING RECORD REVIEW WAS COMPLETED AND NO RELATED NONCONFORMANCES WERE FOUND. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS UNDETERMINABLE. THE DER PROCESS WILL CONTINUE TO MONITOR FOR ANY SIMILAR EVENTS.
IT WAS REPORTED THAT: THE MIK WAS BROKEN AT THE HUB. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE.
IT WAS REPORTED THAT: THE MIK WAS BROKEN AT THE HUB. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2276906 | VSI MICRO-INTRODUCER KITS | INTRODUCER, CATHETER | DYB | VASCULAR SOLUTIONS LLC | 10841156102913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | NOT REPORTED| NOT REPORTED |