MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-28 for WALLFLEX BILIARY M00570380 7038 manufactured by Boston Scientific Corporation.
[140277980]
(b)(4). A fully constrained wallflex biliary rx fully covered stent and delivery system were returned for analysis. Visual examination of the returned device found the clear outer sheath at the guidewire access sheath (gas) section was kinked. The inner shaft at the gas section was detached. Functional evaluation revealed that it was not possible to deploy the stent due to the damaged noted at the gas section; however, the stent was deployed by manually gripping the outer sheath and pulling the tip distally. No other issues were noted to the stent and delivery system. The damages noted to the returned device are consistent with the application of excessive force during use due to resistance encountered during attempted deployment. The investigation concluded that the reported event was likely due procedural factors such as handling of the device, the techniques used by the user, and normal procedural difficulties encountered during the procedure could have possibly affected the device performance and its integrity contributing to the failure experienced by the customer. Therefore, the most probable root cause is adverse event related to the procedure. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
Patient Sequence No: 1, Text Type: N, H10
[140277981]
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was to be used in the duodenum and common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the stent failed to deploy. The procedure was completed with another wallflex biliary stent. There were no patient complications reported as a result of this event. Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the inner shaft/ sheath was detached/separated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01490 |
| MDR Report Key | 8461619 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-06-21 |
| Date Added to Maude | 2019-03-28 |
| 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 | 2019-03-28 |
| Returned To Mfg | 2019-02-08 |
| Model Number | M00570380 |
| Catalog Number | 7038 |
| Lot Number | 0022282307 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-28 |