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 2019-05-10 for WALLFLEX BILIARY M00570370 7037 manufactured by Boston Scientific Corporation.
[144740830]
Age or date of birth: patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). The complainant indicated that the stent remains implanted and the delivery system was disposed; 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
[144740831]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary rx fully covered rmv stent has been implanted to treat a malignant stricture in the mid portion of the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019. Reportedly, the patient's anatomy was dilated prior to stent placement. According to the complainant, during the procedure, the stent was fully deployed; however, the delivery system was difficult to remove. The physician cut the delivery system at the biopsy port, removed the scope and then went back down with a secondary device to remove the remaining portion of the delivery system. Reportedly, the attempted removal of the remaining portion of the delivery system was unsuccessful. The physician planned to remove the delivery system on the next day. The patient was left intubated and was sent to the intensive care unit. The patient's current condition was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02349 |
| MDR Report Key | 8601036 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-10 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2019-02-12 |
| Date Added to Maude | 2019-05-10 |
| 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 | 2019-05-10 |
| Model Number | M00570370 |
| Catalog Number | 7037 |
| Lot Number | 0023333769 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-05-10 |