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.
[138959203]
The complainant was unable to report the suspect device lot number; therefore, the manufacture and expiration dates are unknown. (b)(4). 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
[138959204]
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 during a procedure performed in 2017. Reportedly, the stent was removed during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, the patient presented with pain. During the ercp procedure, the physician grabbed the stent retrieval loop with rat tooth forceps, and the retrieval loop wire broke. Reportedly, each attempt of the physician to pull back the stent on a different area would cause the stent wire to become loose and unraveled. The physician tried to use a snare to grab around the tip of the stent but it did not work. The patient was sent for an open bile duct surgery and the stent was successfully removed. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01273 |
| MDR Report Key | 8425608 |
| 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 | 2019-02-22 |
| 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 | 1. Required No Informationntervention | 2019-03-15 |