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 2018-10-25 for FLEXIMA APDL 31175 manufactured by Boston Scientific Corporation.
[125135479]
It was reported via facility medwatch mw5079751, that the tip broke off. A 12/25 flexima apdl was selected for a ct guided drainage of intra-abdominal abscess with catheter replacement. During procedure, the radiologist dilated the tract and when trying to place the catheter he encountered resistance. Upon trying to remove the catheter, the tip broke off into two pieces. The radiologist was able to retrieve all components of the device and the procedure was completed with a different device. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-62289 |
| MDR Report Key | 8005414 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-07-22 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2018-01-25 |
| Date Added to Maude | 2018-10-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA PROPARK, COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIMA APDL |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-10-25 |
| Model Number | 31175 |
| Catalog Number | 31175 |
| Lot Number | 0021659649 |
| 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 | 2018-10-25 |