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 2019-04-17 for WALLFLEX BILIARY M00570370 7037 manufactured by Boston Scientific Corporation.
[142221130]
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
[142221131]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary rx fully covered rmv stent was to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, during preparation and outside patient, they noticed the corner of the product package's inner sterile pouch was opened. Per the physician, the device was not used on the patient. The procedure was completed with another wallflex biliary stent. There were no patient complications reported as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01733 |
| MDR Report Key | 8522491 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-03-23 |
| Date Mfgr Received | 2019-03-25 |
| Device Manufacturer Date | 2018-08-10 |
| Date Added to Maude | 2019-04-17 |
| 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 | 2019-04-17 |
| Model Number | M00570370 |
| Catalog Number | 7037 |
| Lot Number | 0022489614 |
| 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 | 2019-04-17 |