MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-03-21 for UNKNOWN BIOPSY FORCEPS UNK-BIOPSYFORCEPS manufactured by Cordis Corporation.
[139443917]
This article was found during a recent clinical evaluation review/literature search of this device. The report also represents notification of 1 event for cardiac tamponade. Please note that patient specific details (demographics, medical history and reason for intervention) are not available. The device is the biopsy forceps but the catalog and lot numbers are not available. The citation is as follows (superior accuracy of anatomic positioning with echocardiographic over fluoroscopic-guided endomyocardial biopsy). A copy of the publication is attached to this report. As reported by bell et al. , (1993). Superior accuracy of anatomic positioning with echocardiographic over fluoroscopic guided endomyocardial biopsy. Catheterization and cardiovascular diagnosis 28:291-294; during an endomyocardial biopsy procedure that was performed via the femoral approach using cordis biopsy forceps, one patient with lymphoma experienced cardiac tamponade due to delayed pericardial effusion despite accurate septal bioptome positioning by fluoroscopy. Successful percutaneous pericardial drainage was performed in the catheterization laboratory with prompt restoration of normal hemodynamic status without adverse clinical sequelae. The device was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made. The most common causes of cardiac tamponade are rupture of an aortic aneurysm (a bulge in the wall of the aorta), advanced lung cancer, acute pericarditis (inflammation of the pericardium), a heart attack, and heart surgery. Chest injuries can also cause cardiac tamponade. Procedures requiring biopsy forceps should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to: hematoma at the puncture site; infection; perforation of the vessel wall or the myocardium; vessel trauma; embolism; death. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.
Patient Sequence No: 1, Text Type: N, H10
[139443918]
As reported by bell et al. , (1993). Superior accuracy of anatomic positioning with echocardiographic over fluoroscopic guided endomyocardial biopsy. Catheterization and cardiovascular diagnosis 28:291-294; during an endomyocardial biopsy procedure that was performed via the femoral approach using cordis biopsy forceps, one patient with lymphoma experienced cardiac tamponade due to delayed pericardial effusion despite accurate septal bioptome positioning by fluoroscopy. Successful percutaneous pericardial drainage was performed in the catheterization laboratory with prompt restoration of normal hemodynamic status without adverse clinical sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1016427-2019-02634 |
| MDR Report Key | 8439944 |
| Report Source | LITERATURE |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-21 |
| Date of Event | 1993-01-01 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-03-21 |
| 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 | KARLA CASTRO |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863138372 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer Street | 14201 NW 60TH AVENUE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN BIOPSY FORCEPS |
| Generic Name | DEVICE, BIOPSY, ENDOMYOCARDIAL |
| Product Code | DWZ |
| Date Received | 2019-03-21 |
| Model Number | UNK-BIOPSYFORCEPS |
| Catalog Number | UNK-BIOPSYFORCEPS |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 14201 NW 60TH AVENUE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-03-21 |