SENTINOL NITINOL BILIARY STENT SYSTEM
Report
- Report Number
- 2134265-2011-01230
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 18, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- FGE
- PMA / PMN Number
- K032025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4)
DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A SENTINOL STENT DELIVERY SYSTEM WITH NO ORIGINAL PACKAGING AND A GUIDEWIRE FROZE INSIDE THE SENTINOL DEVICE. VISUAL AND MICROSCOPIC ANALYSIS REVEALED BLOOD WAS VISIBLE INSIDE THE INNER HUB AND THROUGHOUT THE ENTIRE LENGTH OF THE DEVICE. THE SENTINOL DEVICE WAS PLACED IN A WARM CIRCULATING WATER BATH FOR 48 HOURS TO TRY AND SEPARATE THE DEVICES. THIS WAS UNSUCCESSFUL, THE GUIDEWIRE WAS NOT ABLE TO BE REMOVED FROM THE SENTINOL DEVICE. APPROXIMATELY 80.5CM OF THE GUIDEWIRE WAS MEASURED PROTRUDING FROM THE PROXIMAL HUB AND 22CM PROTRUDING FROM THE TIP. THERE IS CLEARANCE BETWEEN THE OD OF THE GUIDEWIRE AND THE ID OF THE INNER MEMBER, AS A LAYER OF BLOOD FILLS THIS GAP CAUSING THE WIRE TO STICK. THIS DELIVERY SYSTEM IS COMPATIBLE WITH A 0.035 INCH GUIDEWIRE, WITH THE ACTUAL GUIDEWIRE TIED TO THIS COMPLAINT MEASURING APPROXIMATELY 0.035 AT ITS MAXIMUM. THERE ARE NO INDICATIONS OF NONCONFORMANCE AS PERTAINING TO THE SENTINOL STENT DELIVERY SYSTEM, OR THE GUIDEWIRE, AND IT APPEARS THAT BLOOD LODGED BETWEEN THE INNER-MEMBER ID AND THE GUIDEWIRE OD MAY BE THE CAUSING FACTOR OF THE WIRE BEING FROZE INSIDE THE SENTINOL DEVICE. THE STENT WAS RETURNED DEPLOYED AND RETURNED WITH THE SENTINOL DEVICE. MICROSCOPIC INSPECTION REVEALED NO DAMAGE OR IRREGULARITIES TO THE STENT OR THE DISTAL END OF THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER RELATED AS THE SENTINOL BILIARY PRODUCT IS INDICATED ONLY FOR USE IN BILIARY STENTING PROCEDURES AND THE RETURNED DEVICE WAS REPORTEDLY USED IN A PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY. (B)(4).
IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT DELIVERY SYSTEM BECAME STUCK ON THE GUIDE WIRE. THE 100% STENOSED DENOVO LESION WAS LOCATED IN THE OSTIUM OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). WHILE LOADING THE 7X20X1350 SENTINOL STENT DELIVERY SYSTEM ONTO A NON BSC GUIDE WIRE, THE DEVICE BECAME STUCK AT ABOUT 100CM ON THE WIRE. UNABLE TO ADVANCE OR WITHDRAW THE STENT DELIVERY SYSTEM BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER NON BSC GUIDE WIRE AND STENT WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.
IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT DELIVERY SYSTEM BECAME STUCK ON THE GUIDE WIRE. THE 100% STENOSED DENOVO LESION WAS LOCATED IN THE OSTIUM OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). WHILE LOADING THE 7X20X1350 SENTINOL STENT DELIVERY SYSTEM ONTO A NON BSC GUIDE WIRE, THE DEVICE BECAME STUCK AT ABOUT 100CM ON THE WIRE. UNABLE TO ADVANCE OR WITHDRAW THE STENT DELIVERY SYSTEM BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER NON BSC GUIDE WIRE AND STENT WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENTINOL NITINOL BILIARY STENT SYSTEM | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC - MAPLE GROVE | H7493894872010 | 12854438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | GUIDE WIRE, VERSA .035| INTRODUCER SHEATH, BALKIN 7F |