MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-28 for FLEXIMA APDL 30935 manufactured by Boston Scientific Corporation.
[146241722]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[146241723]
It was reported that the suture was broken. The target lesion was located in the common bile duct. A flexima apdl drainage catheter was selected for use. During procedure, the suture noted to be broken and the device was then simply pulled out from the patient's body. The procedure was completed with another of the same device. No complications reported and the patient condition was normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-05802 |
| MDR Report Key | 8646163 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-28 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-07-09 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2019-05-28 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| 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 | 2019-05-28 |
| Returned To Mfg | 2019-05-24 |
| Model Number | 30935 |
| Catalog Number | 30935 |
| Lot Number | 0023258723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-28 |