TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
Report
- Report Number
- 3005099803-2010-05151
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Report Date
- November 25, 2010
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- LQC
- PMA / PMN Number
- K040447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
NO CODE AVAILABLE (BASKET WON'T CLOSE). 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. (B)(4).
A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND HEAVY BLACK RESIDUE ON THE DEVICE INDICATING USE AND THE BASKET WAS IN THE RETRACTED POSITION. THE GUIDEWIRE LUMEN (SIDE-CAR) WAS PRESENTED PUSH-BACK AND THE SHEATH WAS FOUND TO BE BUCKLED IN MULTIPLE AREAS. FUNCTIONALLY THE BASKET FAILED TO EXTEND PROPERLY DUE TO THE HEAVY BLACK RESIDUE AND SCRATCHES ON THE HANDLE CANNULA WHICH CAUSED INTERFERENCE BETWEEN THE CANNULA AND THE HANDLE ASSEMBLY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE BASKET WON'T CLOSE. HEAVY CONTRAST RESIDUE AND SCRATCHES FOUND ON THE HANDLE CANNULA CREATED FRICTION AND PREVENTED SMOOTH FUNCTION OF THE DEVICE. SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT VERIFY PRODUCT INTEGRITY, THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED. IT IS LIKELY THAT THE DEVICE WAS DAMAGED DURING THE PROCEDURE; HOWEVER A DEFINITIVE ROOT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A REMOVAL OF A COMMON BILE DUCT STONES PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER SUCCESSFULLY CAPTURING/CRUSHING STONES, THE PHYSICIAN ATTEMPTED TO CAPTURE A 1CM STONE BUT WAS UNABLE TO. AFTER THE FOURTH ATTEMPT THE BASKET WAS UNABLE TO BE CLOSED. THE STONE WAS FINALLY REMOVED ALONG WITH THE DEVICE AND SCOPE, EVEN THOUGH THE BASKET WAS UNABLE TO BE CLOSED, AND THE PROCEDURE WAS COMPLETED. IT COULD NOT BE REPORTED WHETHER ANY DEVICE DAMAGE WAS NOTED AFTER USE, HOWEVER, THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A REMOVAL OF A COMMON BILE DUCT STONES PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER SUCCESSFULLY CAPTURING/CRUSHING STONES, THE PHYSICIAN ATTEMPTED TO CAPTURE A 1CM STONE BUT WAS UNABLE TO. AFTER THE FOURTH ATTEMPT THE BASKET WAS UNABLE TO BE CLOSED. THE STONE WAS FINALLY REMOVED ALONG WITH THE DEVICE AND SCOPE, EVEN THOUGH THE BASKET WAS UNABLE TO BE CLOSED, AND THE PROCEDURE WAS COMPLETED. IT COULD NOT BE REPORTED WHETHER ANY DEVICE DAMAGE WAS NOTED AFTER USE, HOWEVER, THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 | LITHOTRIPTOR, BILIARY MECHANICAL | LQC | BOSTON SCIENTIFIC - SPENCER | M00510890 | 13418961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |