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 2019-05-15 for WALLFLEX DUODENAL M00565020 6502 manufactured by Boston Scientific Corporation.
[145211771]
(b)(4). A wallflex duodenal delivery system was received for analysis; the stent was not returned. Visual examination of the returned device did not find any damages or issues to the delivery system. The investigation concluded that the reported event was most likely due to procedural factors such as handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which may have limited the performance of the device. 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
[145211772]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex duodenal stent was implanted to treat a duodenal obstruction during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the physician had difficulty deploying the stent inside the patient. The stent was able to be deployed but not in the ideal position. The stent was adjusted with a rat tooth or biopsy forceps and the procedure was completed. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02543 |
| MDR Report Key | 8613605 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2018-10-12 |
| Date Added to Maude | 2019-05-15 |
| 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 | 2019-05-15 |
| Returned To Mfg | 2019-04-08 |
| Model Number | M00565020 |
| Catalog Number | 6502 |
| Lot Number | 0022773456 |
| 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 | 1. Required No Informationntervention | 2019-05-15 |