MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN BIOPSY FORCEPS; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number UNK-BIOPSYFORCEPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/01/1993

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: UNKNOWN BIOPSY FORCEPS
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8439944
• MDR Text Key: 139443917
• Report Number: 1016427-2019-02634
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-BIOPSYFORCEPS
• Device Catalogue Number: UNK-BIOPSYFORCEPS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening