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 2018-12-11 for FLEXIMA M001274020 manufactured by Boston Scientific Corporation.
[129947617]
It was reported that the suture broke. A 8/24 flexima drainage catheter was selected for use. During the procedure, it was noted that the string was cut and caused deployment malfunction. Furthermore, the string broke. The patient was taken to the operating room on nov 17 for stent removal and was sent for surgery the next day to complete the procedure. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-63824 |
| MDR Report Key | 8151974 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2018-12-11 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIMA |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-12-11 |
| Model Number | M001274020 |
| Lot Number | 22631739 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-11 |