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 2020-02-20 for WALLFLEX BILIARY M00570370 7037 manufactured by Boston Scientific Corporation.
[188652016]
(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
[188652017]
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex biliary rx fully covered rmv stent was to be used to treat a less than 2 cm benign stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. Reportedly, patient's anatomy was not dilated prior to stent placement. According to the complainant, during the procedure, the stent was able to be deployed. However, under endoscopic visualization, it was noticed that the stent failed to expand. The physician removed the stent with forceps and a 10 x 40 wallflex biliary stent was placed to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00450 |
| MDR Report Key | 9734627 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2020-02-20 |
| 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 CORPORATION |
| 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 | 2020-02-20 |
| Model Number | M00570370 |
| Catalog Number | 7037 |
| Lot Number | 0024029422 |
| 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 | 2020-02-20 |