SPYSCOPE DS
Report
- Report Number
- 3005099803-2019-01042
- Event Type
- Malfunction
- Date Received
- March 4, 2019
- Date of Event
- January 1, 2019
- Report Date
- April 5, 2019
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FBN
- UDI-DI
- 08714729863236
- PMA / PMN Number
- K142922
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE DATE HAS BEEN CHOSEN BASED UPON THE APPROXIMATED DATE PROVIDED BY THE COMPLAINANT. THE PROBLEM CODE 2979 CAPTURES THE REPORTABLE EVENT OF WORKING CHANNEL SLEEVE PROTRUSION. A VISUAL ASSESSMENT WAS PERFORMED AFTER DISINFECTION. AS RECEIVED, THE WORKING CHANNEL SLEEVE (WCS) PROTRUDED. MAXIMUM WCS PROTRUSION REMAINED CONSISTENT WHEN THE DISTAL TIP WAS ARTICULATED BY TURNING THE KNOBS IN ALL DIRECTIONS. THE DISTAL TIP WAS CUT. THE DISTAL CAP WAS REMOVED. THE CATHETER WAS CUT OPEN USING THE CUTTING FIXTURE. THE WCS WAS REMOVED. WITNESS MARKS WERE NOTED ON THE PEBAX. THE WHITE AND CLEAR AREAS ALONG BOND A APPEARED TO SHOW EVIDENCE OF ADHESION. THE COMPLAINT WAS CONSISTENT WITH THE REPORTED COMPLAINT INCIDENT OF WORKING CHANNEL SLEEVE PROTRUDING. BASED ON INVESTIGATION RESULTS, THE UNDERLYING CAUSE OF WORKING CHANNEL SLEEVE PROTRUSION IS AN INSUFFICIENT BOND, PARTICULARLY THE SECOND HEAT CYCLE OF THE WORKING CHANNEL SLEEVE BONDING PROCESS [BOND B]. WORKING CHANNEL SLEEVE PROTRUSION IN DEVICES MANUFACTURED POST 01MAR2018 CHANGES HAS BEEN DETERMINED TO BE A DESIGN ISSUE, THEREFORE, THE COMPLAINT INVESTIGATION CONCLUSION CODE SELECTED FOR THE WORKING CHANNEL SLEEVE PROTRUSION ISSUE IS DESIGN INADEQUATE FOR PURPOSE, WHICH INDICATES THAT PROBLEMS WERE TRACED TO DESIGN/DESIGN FEATURES OF THE DEVICE THAT DO NOT SUPPORT OR DO INTERFERE WITH THE INTENDED PURPOSE OF THE DEVICE. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND DID NOT IDENTIFY EVIDENCE OF DEVIATIONS OR NON-CONFORMANCES IN THE MANUFACTURING PROCESSES THAT COULD CONTRIBUTE TO THE COMPLAINT. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS AND A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO ACCESSORY DEVICE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. A HURRICANE RX DILATATION BALLOON WAS ALSO USED AND THE BALLOON BURST. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON AND A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS AND A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO ACCESSORY DEVICE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. A HURRICANE RX DILATATION BALLOON WAS ALSO USED AND THE BALLOON BURST. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON AND A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
THE DATE HAS BEEN CHOSEN BASED UPON THE APPROXIMATED DATE PROVIDED BY THE COMPLAINANT. (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS AND A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO ACCESSORY DEVICE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. A HURRICANE RX DILATATION BALLOON WAS ALSO USED AND THE BALLOON BURST. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON AND A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181024 | SPYSCOPE DS | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FBN | BOSTON SCIENTIFIC CORPORATION | M00546600 | 22710968 | 08714729863236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |