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 2019-03-12 for WALLFLEX DUODENAL M00565020 6502 manufactured by Boston Scientific Corporation.
[138580197]
The complainant was unable to provide the suspect device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). The complainant indicated that the suspect device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[138580198]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex duodenal stent has been implanted to treat a malignant stricture in the duodenum during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2017. Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement. During the initial placement, the stent was slightly adjusted with rat tooth forceps. According to the complainant, on (b)(6) 2019, the patient presented with pain. The physician performed direct visualization to check for stent placement, and noticed that the wires at the end of the stent were exposed and were not joined/ connected. Reportedly, the stent remains implanted and the physician was comfortable leaving the stent in place. It is unknown if the patient received any treatment for pain. 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 | 3005099803-2019-01117 |
| MDR Report Key | 8413985 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-03-12 |
| 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 DUODENAL |
| Generic Name | STENT,METALLIC,EXPANDABLE,DUODENAL |
| Product Code | MUM |
| Date Received | 2019-03-12 |
| Model Number | M00565020 |
| Catalog Number | 6502 |
| 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 | 2019-03-12 |