TRAPEZOID? RX
Report
- Report Number
- 3005099803-2013-05575
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 30, 2013
- Report Date
- May 30, 2013
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- LQC
- PMA / PMN Number
- K040447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE BASKET WAS PARTIALLY OPEN UPON RECEIPT. THE HANDLE CANNULA WAS FOUND TO HAVE SEPARATED FROM THE THUMB RING. THE PROXIMAL END OF THE HANDLE CANNULA HAD DEFORMATION MARKS FROM THE HANDLE SET SCREWS AND FROM BEING PULLED OUT OF THE THUMB RING. THESE SET SCREW MARKS AND SCORING INDICATE THAT THE HANDLE CANNULA WAS PROPERLY SECURED IN THE THUMB RING DURING MANUFACTURING. NO OTHER DAMAGE TO THE DEVICE WAS FOUND. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE WIRE OF THE HANDLE DETACHED. REPORTEDLY, THE DEVICE WAS USED IN THE PANCREAS. USE OF THE DEVICE IN THE PANCREAS COULD CAUSE THE DEVICE TO BE UNDER TORTUOUS CONDITION, WHICH CAN CAUSE THE DEVICE TO BEND/COIL LEADING TO INCREASED ACTUATION FORCE, POSSIBLY CAUSING THE OBSERVED ISSUE OF THE HANDLE CANNULA SEPARATING FROM THE THUMB RING. THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DIRECTIONS FOR USE (DFU) SPECIFIES: "CAUTION: TRAPEZOID RX WIREGUIDED RETRIEVAL BASKET IS NOT INTENDED FOR USE IN THE PANCREAS." THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS USER/USE ERROR. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.
REPORTED EVENT OF HANDLE BREAK. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED THERE WAS ONE OR MORE PANCREATIC STONE(S) IN THE PANCREATIC DUCT. THE PHYSICIAN ADVANCED THE DEVICE VIA THE GUIDEWIRE AND OPENED THE BASKET TO GRASP A PANCREATIC STONE. THE WIRE OF THE HANDLE DETACHED AND THE BASKET WAS UNABLE TO OPEN OR CLOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ADDITIONALLY, THIS DEVICE IS NOT INDICATED FOR USE WITHIN THE PANCREATIC DUCT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED THERE WAS ONE OR MORE PANCREATIC STONE(S) IN THE PANCREATIC DUCT. THE PHYSICIAN ADVANCED THE DEVICE VIA THE GUIDEWIRE AND OPENED THE BASKET TO GRASP A PANCREATIC STONE. THE WIRE OF THE HANDLE DETACHED AND THE BASKET WAS UNABLE TO OPEN OR CLOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ADDITIONALLY, THIS DEVICE IS NOT INDICATED FOR USE WITHIN THE PANCREATIC DUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282185 | TRAPEZOID? RX | LITHOTRIPTOR, BILIARY MECHANICAL | LQC | BOSTON SCIENTIFIC - SPENCER | M00510860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |