WALLFLEX ¿ DUODENAL
Report
- Report Number
- 3005099803-2013-00769
- Event Type
- Malfunction
- Date Received
- February 5, 2013
- Date of Event
- January 12, 2013
- Report Date
- January 14, 2013
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- MUM
- PMA / PMN Number
- K062750
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. IT WAS NOTED THAT THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. THE OUTER SHEATH WAS STRETCHED FOR A DISTANCE OF APPROXIMATELY 140 MM FROM THE HANDLE BREAK. DURING A FUNCTIONAL ANALYSIS, IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH TO DEPLOY THE STENT SO THE SHAFT WAS DISSECTED PROXIMAL TO THE STENT AND THE INNER SHAFT AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER SHAFT. NO ISSUES WERE NOTED WITH THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. THE OUTER SHEATH WAS DISSECTED LONGITUDINALLY AND IT WAS NOTED THAT SOME OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.
(B)(4).
ALTHOUGH THE EXACT PATIENT AGE WAS NOT PROVIDED, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 WALLFLEX ENTERAL DUODENAL STENT SYSTEM WAS USED DURING A DUODENAL STENTING PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A MALIGNANCY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ENDOSCOPE ACROSS THE LESION TO DETERMINE THE LESION'S LENGTH. THE PHYSICIAN THEN POSITIONED THE STENT SYSTEM AT THE TARGET SIZE UNDER FLUOROSCOPY AND BEGAN DEPLOYMENT. DURING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE AND COULD NOT FULLY RELEASE THE STENT. THE PHYSICIAN RECONSTRAINED THE STENT AND ATTEMPTED DEPLOYMENT AGAIN. HOWEVER, THE STENT GOT STUCK AT THE SAME POINT AND WOULD NOT FULLY RELEASE. THE PHYSICIAN THEN TRIED TO PUSH THE CATHETER FURTHER TO DEPLOY THE STENT BUT AT THIS TIME THE CATHETER BROKE. THE ENTIRE STENT SYSTEM WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS "DOING FINE" FOLLOWING THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT SYSTEM WAS USED DURING A DUODENAL STENTING PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A MALIGNANCY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ENDOSCOPE ACROSS THE LESION TO DETERMINE THE LESION'S LENGTH. THE PHYSICIAN THEN POSITIONED THE STENT SYSTEM AT THE TARGET SIZE UNDER FLUOROSCOPY AND BEGAN DEPLOYMENT. DURING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE AND COULD NOT FULLY RELEASE THE STENT. THE PHYSICIAN RECONSTRAINED THE STENT AND ATTEMPTED DEPLOYMENT AGAIN. HOWEVER, THE STENT GOT STUCK AT THE SAME POINT AND WOULD NOT FULLY RELEASE. THE PHYSICIAN THEN TRIED TO PUSH THE CATHETER FURTHER TO DEPLOY THE STENT BUT AT THIS TIME THE CATHETER BROKE. THE ENTIRE STENT SYSTEM WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS "DOING FINE" FOLLOWING THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. **ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2013** ACCORDING TO THE COMPLAINANT, IT WAS THE HANDLE THAT BROKE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT SYSTEM WAS USED DURING A DUODENAL STENTING PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A MALIGNANCY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ENDOSCOPE ACROSS THE LESION TO DETERMINE THE LESION'S LENGTH. THE PHYSICIAN THEN POSITIONED THE STENT SYSTEM AT THE TARGET SIZE UNDER FLUOROSCOPY AND BEGAN DEPLOYMENT. DURING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE AND COULD NOT FULLY RELEASE THE STENT. THE PHYSICIAN RECONSTRAINED THE STENT AND ATTEMPTED DEPLOYMENT AGAIN. HOWEVER, THE STENT GOT STUCK AT THE SAME POINT AND WOULD NOT FULLY RELEASE. THE PHYSICIAN THEN TRIED TO PUSH THE CATHETER FURTHER TO DEPLOY THE STENT BUT AT THIS TIME THE CATHETER BROKE. THE ENTIRE STENT SYSTEM WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS "DOING FINE" FOLLOWING THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2013. ACCORDING TO THE COMPLAINANT, IT WAS THE HANDLE THAT BROKE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT SYSTEM WAS USED DURING A DUODENAL STENTING PROCEDURE ON (B)(6), 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A MALIGNANCY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ENDOSCOPE ACROSS THE LESION TO DETERMINE THE LESION'S LENGTH. THE PHYSICIAN THEN POSITIONED THE STENT SYSTEM AT THE TARGET SIZE UNDER FLUOROSCOPY AND BEGAN DEPLOYMENT. DURING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE AND COULD NOT FULLY RELEASE THE STENT. THE PHYSICIAN RECONSTRAINED THE STENT AND ATTEMPTED DEPLOYMENT AGAIN. HOWEVER, THE STENT GOT STUCK AT THE SAME POINT AND WOULD NOT FULLY RELEASE. THE PHYSICIAN THEN TRIED TO PUSH THE CATHETER FURTHER TO DEPLOY THE STENT BUT AT THIS TIME THE CATHETER BROKE. THE ENTIRE STENT SYSTEM WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER WALLFLEX ENTERAL DUODENAL STENT SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS "DOING FINE" FOLLOWING THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48640 | WALLFLEX ¿ DUODENAL | STENT,METALLIC,EXPANDABLE,DUODENAL | MUM | BOSTON SCIENTIFIC - GALWAY | M00565030 | 0015152178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |