MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-15 for WALLFLEX BILIARY M00570370 7037 manufactured by Boston Scientific Corporation.
[138946356]
The complainant was unable to provide the suspect device lot number; therefore, the manufacture and expiration dates are unknown. The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[138946357]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary rx fully covered rmv stent was implanted in the common bile duct three (3) months ago for chronic pancreatitis during a procedure performed on an unknown date. According to the complainant, during an endoscopic retrograde cholangiopancreatographty (ercp) procedure performed on (b)(6) 2019 the physician was removing the wallflex biliary rx fully covered rmv stent. It was reported that the stent unraveled. The procedure was completed with this device. There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported to be fine. Note: despite numerous attempts, boston scientific has been unable obtain additional information regarding the circumstances surrounding this event. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01260 |
| MDR Report Key | 8424968 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLFLEX BILIARY |
| Generic Name | BILIARY STENT SYSTEM FOR BENIGN STRICTURES |
| Product Code | PNB |
| Date Received | 2019-03-15 |
| Model Number | M00570370 |
| Catalog Number | 7037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-15 |