TRAPEZOID¿ RX
Report
- Report Number
- 3005099803-2012-00611
- Event Type
- Death
- Date Received
- March 2, 2012
- Date of Event
- February 9, 2012
- Report Date
- February 10, 2012
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- LQC
- PMA / PMN Number
- K040447
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
THE REPORTED EVENT OF TIP WON'T DETACH. REPORTED EVENT OF PULLWIRE 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.
A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL PORTION OF THE TRAPEZOID DEVICE, INCLUDING THE BASKET WAS NOT RETURNED FOR ANALYSIS. THE WORKING LENGTH OF THE DEVICE WAS SEPARATED AT APPROXIMATELY 2.4 CM DISTALLY FROM THE HEAT SHRINK. AN EXAMINATION OF THE PULL WIRE UNDER MAGNIFICATION REVEALED THAT IT WAS CUT, INDICATING THAT IT DID NOT FAIL WHILE UNDERGOING TENSILE FORCE. THE THUMB RING WAS CRUSHED, MOST LIKELY FROM PRESSURE APPLIED BY THE ALLIANCE HANDLE. ADDITIONALLY, THE SHEATH WAS TORN. AS THE ENTIRE DEVICE WAS NOT RETURNED, IT WAS NOT POSSIBLE TO PERFORM A COMPLETE INSPECTION ON THE DEVICE. THEREFORE IS IT NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE DEVICE THAT COULD HAVE CONTRIBUTED TO THIS EVENT. SINCE THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. 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).
(B)(4).
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE (B)(6) MALE PATIENT WAS ALREADY HOSPITALIZED IN THE ICU FOR ACUTE CHOLECYSTITIS, AND SEVERE UPPER GASTROINTESTINAL BLEEDING DUE TO ULCERS. AFTER SURGERY WAS REFUSED, AN ERCP PROCEDURE WAS INDICATED FOR STONE REMOVAL DURING THIS HOSPITALIZATION. AN ERCP BEGAN WITH GUIDEWIRE CANNULATION AND A SPHINCTEROTOMY WAS SUCCESSFULLY COMPLETED. A BILIARY BALLOON WAS INTRODUCED TO REMOVE SLUDGE AND DEBRIS. AFTER INJECTION OF CONTRAST, A 1CM STONE WAS VISUALIZED AT THE CONVERGENCE OF THE CYSTIC DUCT. A TRAPEZOID BASKET WAS USED IN AN ATTEMPT TO REMOVE THE STONE, HOWEVER THIS WAS UNSUCCESSFUL. AN ATTEMPT WAS MADE TO CRUSH THE STONE USING THE ALLIANCE HANDLE HOWEVER THE STONE WAS UNABLE TO BE CRUSHED, AND THE TIP FAILED TO DETACH. THE PULLWIRE BROKE AND THE BASKET COULD NOT BE REOPENED. THEREFORE, THE HANDLE OF THE BASKET WAS CUT AND THE SHEATH WAS REMOVED THROUGH THE NOSE OF THE PATIENT. DURING THE SAME PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE BASKET AND WIRE FROM THE PATIENT, HOWEVER THIS WAS UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO MAKE A MACRO DILATION OF THE SPHINCTEROTOMY WITH A COOK BALLOON BUT WAS UNABLE TO REMOVE THE BASKET. THE PHYSICIAN THEN PLACED A COOK PLASTIC BILIARY STENT FOR BILIARY DRAINAGE. IT WAS REPORTED THAT THE PROCEDURE LASTED 3 HOURS, AND THAT THE PATIENT WAS UNDER ANESTHESIA (UNKNOWN TYPE OF ANESTHESIA) LONGER THAN ANTICIPATED. THE PHYSICIAN PLANNED ON REMOVING THESE DEVICES FROM THE PATIENT DURING A SEPARATE PROCEDURE ON A LATER DATE. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED BACK TO THE ICU AND KEPT UNDER SEDATION. THE PATIENT REMAINED SEDATED WHILE IN THE ICU, AND THE PHYSICIAN DECIDED TO NOT PROCEED WITH ANOTHER SURGERY. THE PATIENT WAS DIAGNOSED WITH MULTI-SYSTEM ORGAN FAILURE AND DIED. THE EXACT CAUSE OF DEATH IS UNKNOWN AND THERE WAS NO AUTOPSY. ACCORDING TO THE PHYSICIAN, THE EXTENDED ANESTHESIA LED TO A DROP IN CARDIAC OUTPUT AND EVENTUAL ORGAN FAILURE. IT WAS REPORTED THAT THE PATIENT DIED "SOMETIME OVER THE FOLLOWING WEEKEND" BETWEEN (B)(6) 2012. THE EXACT DATE OF DEATH IS NOT KNOWN.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS ALREADY HOSPITALIZED IN THE ICU FOR ACUTE CHOLECYSTIS, AND SEVERE UPPER GASTROINTESTINAL BLEEDING DUE TO ULCERS. AN ERCP LITHOTRIPSY PROCEDURE WAS INDICATED FOR STONE REMOVAL DURING THIS HOSPITALIZATION. DURING THE PROCEDURE, WHEN AN ATTEMPT WAS MADE TO CRUSH THE STONE USING THE ALLIANCE HANDLE, THE STONE WAS UNABLE TO BE CRUSHED, AND THE TIP FAILED TO DETACH. THE PULLWIRE BROKE AND THE BASKET COULD NOT BE REOPENED. THEREFORE, THE HANDLE OF THE BASKET WAS CUT AND THE SHEATH WAS REMOVED THROUGH THE NOSE OF THE PATIENT. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE BASKET AND WIRE FROM THE PATIENT, HOWEVER, THIS WAS UNSUCCESSFUL. THE PHYSICIAN PLACED A COOK PLASTIC BILIARY STENT. IT WAS REPORTED THAT THE PROCEDURE LASTED 3 HOURS, AND THAT THE PATIENT WAS UNDER ANESTHESIA LONGER THAN ANTICIPATED. THE PHYSICIAN PLANNED ON REMOVING THESE DEVICES FROM THE PATIENT DURING A SEPARATE PROCEDURE ON A LATER DATE. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED BACK TO THE ICU STILL UNDER SEDATION. THE PATIENT REMAINED SEDATED WHILE IN THE ICU, WAS DIAGNOSED WITH MULTI-SYSTEM ORGAN FAILURE AND DIED. THE EXACT CAUSE OF DEATH IS UNKNOWN AND THERE WAS NO AUTOPSY. IT WAS REPORTED THAT THE PATIENT DIED "SOMETIME OVER THE FOLLOWING WEEKEND" BETWEEN (B)(6) AND (B)(6) 2012. THE EXACT DATE OF DEATH IS NOT KNOWN.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP PROCEDURE ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, THE (B)(6) MALE PATIENT WAS ALREADY HOSPITALIZED IN THE ICU FOR ACUTE CHOLECYSTITIS, AND SEVERE UPPER GASTROINTESTINAL BLEEDING DUE TO ULCERS. AFTER SURGERY WAS REFUSED, AN ERCP PROCEDURE WAS INDICATED FOR STONE REMOVAL DURING THIS HOSPITALIZATION. AN ERCP BEGAN WITH GUIDEWIRE CANNULATION AND A SPHINCTEROTOMY WAS SUCCESSFULLY COMPLETED. A BILIARY BALLOON WAS INTRODUCED TO REMOVE SLUDGE AND DEBRIS. AFTER INJECTION OF CONTRAST, A 1CM STONE WAS VISUALIZED AT THE CONVERGENCE OF THE CYSTIC DUCT. A TRAPEZOID BASKET WAS USED IN AN ATTEMPT TO REMOVE THE STONE, HOWEVER THIS WAS UNSUCCESSFUL. AN ATTEMPT WAS MADE TO CRUSH THE STONE USING THE ALLIANCE HANDLE HOWEVER THE STONE WAS UNABLE TO BE CRUSHED, AND THE TIP FAILED TO DETACH. THE PULLWIRE BROKE AND THE BASKET COULD NOT BE REOPENED. THEREFORE, THE HANDLE OF THE BASKET WAS CUT AND THE SHEATH WAS REMOVED THROUGH THE NOSE OF THE PATIENT. DURING THE SAME PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE BASKET AND WIRE FROM THE PATIENT, HOWEVER THIS WAS UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO MAKE A MACRO DILATION OF THE SPHINCTEROTOMY WITH A COOK BALLOON BUT WAS UNABLE TO REMOVE THE BASKET. THE PHYSICIAN THEN PLACED A COOK PLASTIC BILIARY STENT FOR BILIARY DRAINAGE. IT WAS REPORTED THAT THE PROCEDURE LASTED 3 HOURS, AND THAT THE PATIENT WAS UNDER ANESTHESIA (UNKNOWN TYPE OF ANESTHESIA) LONGER THAN ANTICIPATED. THE PHYSICIAN PLANNED ON REMOVING THESE DEVICES FROM THE PATIENT DURING A SEPARATE PROCEDURE ON A LATER DATE. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED BACK TO THE ICU AND KEPT UNDER SEDATION. THE PATIENT REMAINED SEDATED WHILE IN THE ICU, AND THE PHYSICIAN DECIDED TO NOT PROCEED WITH ANOTHER SURGERY. THE PATIENT WAS DIAGNOSED WITH MULTI-SYSTEM ORGAN FAILURE AND DIED. THE EXACT CAUSE OF DEATH IS UNKNOWN AND THERE WAS NO AUTOPSY. ACCORDING TO THE PHYSICIAN, THE EXTENDED ANESTHESIA LED TO A DROP IN CARDIAC OUTPUT AND EVENTUAL ORGAN FAILURE. IT WAS REPORTED THAT THE PATIENT DIED "SOMETIME OVER THE FOLLOWING WEEKEND" BETWEEN (B)(6), 2012. THE EXACT DATE OF DEATH IS NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRAPEZOID¿ RX | LITHOTRIPTOR, BILIARY MECHANICAL | LQC | BOSTON SCIENTIFIC - SPENCER | M00510880 | 14660248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Death| R |