WALLFLEX? COLONIC
Report
- Report Number
- 3005099803-2013-03362
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 15, 2013
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- MQR
- PMA / PMN Number
- K061877
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE OUTER SHEATH HAD BEEN FULLY RETRACTED AND THE STENT HAD BEEN DEPLOYED FROM THE DEVICE AND WAS NOT RETURNED. THE CLEAR OUTER SHEATH WAS KINKED AT SEVERAL LOCATIONS ALONG ITS LENGTH. IT WAS NOTED THAT THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH AND WAS NOT RETURNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. THE STAINLESS STEEL SHAFT WAS KINKED AND DAMAGED FOR A DISTANCE OF 105 MM DISTAL TO THE DISTAL END OF THE PROXIMAL HANDLE. 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 OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU)/PRODUCT LABEL. THE DFU STATES "THE DEVICE IS INDICATED FOR THE PALLIATIVE TREATMENT OF COLONIC STRICTURES PRODUCED BY MALIGNANT NEOPLASM AND TO RELIEVE LARGE BOWEL OBSTRUCTION PRIOR TO COLECTOMY IN PATIENTS WITH MALIGNANT STRICTURES. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN BENIGN STRICTURES HAVE NOT BEEN ESTABLISHED." HOWEVER, THE COMPLAINT STATES THAT THE STENT WAS USED AS A BRIDGE TO SURGERY FOR A BENIGN TUMOR. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO USE/USER ERROR, PERFORMANCE OF THE DEVICE WAS LIMITED.
ALTHOUGH THE EXACT PATIENT AGE WAS NOT PROVIDED, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE.(B)(4).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.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS. REFER TO MANUFACTURER REPORT # 3005099803-2013-03350 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT AND A WALLFLEX ENTERAL DUODENAL STENT WERE USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6), 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT PROCEDURE WAS AS A BRIDGE TO SURGERY FOR A BENIGN TUMOR WITHIN THE DESCENDING COLON. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. DURING THE PROCEDURE, WHEN TRYING TO DEPLOY THE WALLFLEX ENTERAL COLONIC STENT (THE SUBJECT OF THIS REPORT), RESISTANCE WAS FELT WHEN TRYING TO DEPLOY THE LAST 2CMS OF THE STENT AND THE WHITE HANDLE DETACHED. THEY TRIED TO DEPLOY THE STENT WITH DIFFERENT METHODS AND THE STENT EVENTUALLY DEPLOYED, BUT DUE TO MANIPULATION IT WAS PLACED TOO FAR PROXIMAL FROM THE LESION. A WALLFLEX ENTERAL DUODENAL STENT DEVICE (THE SUBJECT OF MFR. REPORT # 3005099803-2013-03350) WAS THEN PLACED WITHIN THE WALLFLEX ENTERAL COLONIC STENT WITHOUT ANY ISSUE. IT WAS REPORTED THAT DURING THE WEEKEND FOLLOWING THE PLACEMENT OF THE STENTS, THE WALLFLEX ENTERAL DUODENAL STENT STARTED PUSHING ON THE WALLFLEX ENTERAL COLONIC STENT AND CAUSED A MICRO-PERFORATION. IN THE PHYSICIAN'S ASSESSMENT, IT WAS UNABLE TO BE DETERMINED WHICH STENT CAUSED THE PERFORATION. AS THE STENTS WERE INITIALLY PLACED AS A BRIDGE TO SURGERY, THE PLANNED SURGERY FOR THE PATIENT WAS EXPEDITED AND BOTH STENTS WERE REMOVED. THE PATIENT WAS REPORTED TO BE STABLE POST SURGERY.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS. REFER TO MANUFACTURER REPORT # 3005099803-2013-03350 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT AND A WALLFLEX ENTERAL DUODENAL STENT WERE USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT PROCEDURE WAS AS A BRIDGE TO SURGERY FOR A BENIGN TUMOR WITHIN THE DESCENDING COLON. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. DURING THE PROCEDURE, WHEN TRYING TO DEPLOY THE WALLFLEX ENTERAL COLONIC STENT (THE SUBJECT OF THIS REPORT), RESISTANCE WAS FELT WHEN TRYING TO DEPLOY THE LAST 2CMS OF THE STENT AND THE WHITE HANDLE DETACHED. THEY TRIED TO DEPLOY THE STENT WITH DIFFERENT METHODS AND THE STENT EVENTUALLY DEPLOYED, BUT DUE TO MANIPULATION IT WAS PLACED TOO FAR PROXIMAL FROM THE LESION. A WALLFLEX ENTERAL DUODENAL STENT DEVICE (THE SUBJECT OF MFR. REPORT # 3005099803-2013-03350) WAS THEN PLACED WITHIN THE WALLFLEX ENTERAL COLONIC STENT WITHOUT ANY ISSUE. IT WAS REPORTED THAT DURING THE WEEKEND FOLLOWING THE PLACEMENT OF THE STENTS, THE WALLFLEX ENTERAL DUODENAL STENT STARTED PUSHING ON THE WALLFLEX ENTERAL COLONIC STENT AND CAUSED A MICRO-PERFORATION. IN THE PHYSICIAN¿S ASSESSMENT, IT WAS UNABLE TO BE DETERMINED WHICH STENT CAUSED THE PERFORATION. AS THE STENTS WERE INITIALLY PLACED AS A BRIDGE TO SURGERY, THE PLANNED SURGERY FOR THE PATIENT WAS EXPEDITED AND BOTH STENTS WERE REMOVED. THE PATIENT WAS REPORTED TO BE STABLE POST SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203643 | WALLFLEX? COLONIC | STENT, COLONIC, METALIC, EXPANDABLE | MQR | BOSTON SCIENTIFIC - GALWAY | M00565060 | 15731996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |