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 Ventricular Fibrillation (2130)

Event Date 12/09/2014

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 ventricular fibrillation.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: "awad - endomyocardial biopsy technique for orthotopic heart transplantation and cardiac stem-cell harvesting".As reported in the literature article by awad, m., ruzza, a., soliman, c., pinzás, j., marban, e., trento, a., & czer, l.(2014), "endomyocardial biopsy technique for orthotopic heart transplantation and cardiac stem-cell harvesting." transplantation proceedings, 46 (10), 3580-3584.Doi: 10.1016/j.Transproceed.2014.05.084; a biopsy procedure was performed after orthotopic heart transplantation (oht) with the bicaval technique using cordis bioptome, and there was one occurrence of ventricular fibrillation requiring cardioversion, and no occurrence of cardiac tamponade during the procedure.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.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 in the literature article by awad, m., ruzza, a., soliman, c., pinzás, j., marban, e., trento, a., & czer, l.(2014), "endomyocardial biopsy technique for orthotopic heart transplantation and cardiac stem-cell harvesting." transplantation proceedings, 46 (10), 3580-3584.Doi: 10.1016/j.Transproceed.2014.05.084; a biopsy procedure was performed after orthotopic heart transplantation (oht) with the bicaval technique using cordis bioptome, and there was one occurrence of ventricular fibrillation requiring cardioversion, and no occurrence of cardiac tamponade during the procedure.

• 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: 8488899
• MDR Text Key: 141104298
• Report Number: 1016427-2019-02684
• 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: Other
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/05/2019
• 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