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 2019-05-31 for WALLFLEX BILIARY M00570370 7037 manufactured by Boston Scientific Corporation.
[146663168]
(b)(4). The complainant reported that the stent remained implanted but the delivery system is available for return. However, the device has not yet been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[146663169]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary rx fully covered stent has been implanted to treat a malignant stricture in the distal common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure on (b)(6) 2019. According to the complainant, during the procedure, it was very difficult to retract the sheath off the stent, but the stent was able to be deployed. However, it was noticed that the inner catheter was separated from the delivery system upon removal of the device from the patient. Reportedly, when the delivery system was pulled out from the scope, the inner catheter remained sticking out the distal end of the scope while the rest of the delivery system was fully removed from the biopsy channel. The physician was able to grab the inner catheter at the distal end of the scope and pulled it out from the scope channel. Reportedly, the stent remains implanted. 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 | 3005099803-2019-02737 |
| MDR Report Key | 8658504 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-31 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-06-26 |
| Device Manufacturer Date | 2018-11-09 |
| Date Added to Maude | 2019-05-31 |
| 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 | 2019-05-31 |
| Returned To Mfg | 2019-06-06 |
| Model Number | M00570370 |
| Catalog Number | 7037 |
| Lot Number | 0022915793 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-05-31 |