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 2019-03-07 for WALLFLEX BILIARY M00570370 56424 manufactured by Boston Scientific Corporation.
[138084850]
The complainant was unable to provide the suspect device lot number; therefore, the manufacture and expiration dates are unknown. (b)(4). The device has been received for analysis; however the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. 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.
Patient Sequence No: 1, Text Type: N, H10
[138084851]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary rx fully covered rmv stent was removed during an endoscopic retrograde cholangiopancreatography (ercp) with stent removal procedure performed on (b)(6) 2019. Reportedly, the stent was implanted a month ago. According to the complainant, during removal, the physician pulled the stent using a disposable rat tooth forceps, and suddenly the stent unraveled and broke apart; exposing the sharp wire edges of the stent wire in the common bile duct. A retrieval balloon catheter was used to inflate the distal end of the stent, and pulled the stent down, and then a snare was used to pull the stent out from the patient. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01071 |
| MDR Report Key | 8398767 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-07 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-03-07 |
| 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 | 2019-03-07 |
| Model Number | M00570370 |
| Catalog Number | 56424 |
| 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 | 2019-03-07 |