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 2019-11-26 for WALLFLEX BILIARY M00570370 7037 manufactured by Boston Scientific Corporation.
[168442709]
(b)(4). The complainant indicated that the stent remains implanted but the delivery system will be available for returned; however, the device has not 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 medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[168442710]
It was reported to boston scientific corporation on november 5, 2019 that a wallflex biliary rx fully covered rmv stent has been implanted in the 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 was able to be deployed. However, during removal of the delivery system, the catheter got stuck inside the stent. Reportedly, the physician made several attempts to release the delivery system from the stent but it was unsuccessful and the delivery system broke into two pieces. The physician went to retrieve the broken portion of the delivery system that was still stuck inside the stent, but it was extremely difficult to remove. The physician switched from ercp scope to an esophagogastroduodenoscopy (egd) scope and was able to successfully grab the broken pieces and removed it from the patient. Cholangiogram was performed and confirmed no defects were found. The stent remains implanted and the procedure was completed. There were no patient complication reported as a result of this event. Despite numerous attempts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-05801 |
| MDR Report Key | 9379319 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2019-11-05 |
| Device Manufacturer Date | 2018-08-31 |
| Date Added to Maude | 2019-11-26 |
| 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 | 2019-11-26 |
| Model Number | M00570370 |
| Catalog Number | 7037 |
| Lot Number | 0022592922 |
| 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 | 2019-11-26 |