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 2017-08-03 for COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS N/A FBF-5.2-120 manufactured by Cook Inc.
[81749557]
Common name: device, biopsy, endomyocardial. Product code: dwz. (b)(4). The event is currently under investigation. A supplemental report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[81749558]
It is alleged that a patient experienced a pericardial effusion after a physician used a cook flexible myocardial biopsy forceps product set for a myocardial biopsy procedure. The complainant reported that the use of the cook flexible myocardial biopsy forceps was successful and the product worked as it should. However, a puncture to the right v. Femoralis was reported in relation to an "angiokit. " the pericardial effusion was successfully stopped with a tamponade, and it has not been reported that the patient experienced any further adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-02107 |
| MDR Report Key | 6764953 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-03 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-11-28 |
| Device Manufacturer Date | 2017-05-12 |
| Date Added to Maude | 2017-08-03 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2017-08-03 |
| Model Number | N/A |
| Catalog Number | FBF-5.2-120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-08-03 |