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

Catalog Number UNK-BIOPSYFORCEPS

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

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

This article was found during a recent literature search of this device.Please note that patient specific details (demographics, medical history, and reason for intervention) are not available.The device is cordis biopsy forceps but the catalog and lot numbers are not available.A copy of the publication is attached to this report.The citation is as follows: amitai et al.(2007)."comparison of three-dimensional echocardiography to two-dimensional echocardiography and fluoroscopy for monitoring of endomyocardial biopsy." the american journal of cardiology.Am j cardiol; 99: 64 ¿ 866, doi: 10.1016/j.Amjcard.2006.10.050.As reported in the literature article by amitai et al., (2007)."comparison of three-dimensional echocardiography to two-dimensional echocardiography and fluoroscopy for monitoring of endomyocardial biopsy." the american journal of cardiology.Am j cardiol; 99: 864 ¿ 866, doi: 10.1016/j.Amjcard.2006.10.050; during an endomyocardial biopsy (emb) procedure using cordis disposable bioptomes, one clinical complication occurred with documented perforation that resulted in cardiac tamponade.The device was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) reviews could not be performed.Given the limited information provided, the reported events ¿perforation¿ and ¿cardiac tamponade¿ could not be confirmed and the exact root cause could not be determined.According to the instructions for use (ifu), 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 and are listed on the ifu.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, and death.Cardiac tamponade is a serious medical condition in which blood or fluids fill the space between the sac that encases the heart and the heart muscle.This places extreme pressure on your heart.The pressure prevents the heart's ventricles from expanding fully and keeps your heart from functioning properly.Vessel perforation may cause cardiac tamponade, as was reported in this case.Additionally, vessel characteristics and procedural/handling factors may have contributed to the reported event.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.This is one of two products involved with the same literature article and the associated manufacturer report number is 1016427-2019-02680.

Event Description

As reported in the literature article by amitai et al., (2007)."comparison of three-dimensional echocardiography to two-dimensional echocardiography and fluoroscopy for monitoring of endomyocardial biopsy." the american journal of cardiology.Am j cardiol; 99: 864 ¿ 866, doi: 10.1016/j.Amjcard.2006.10.050; during an endomyocardial biopsy (emb) procedure using cordis disposable bioptomes, one clinical complication occurred with documented perforation that resulted in cardiac tamponade.

• Brand Name: UNKNOWN BIOPSY FORCEPS
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8478378
• MDR Text Key: 140768478
• Report Number: 1016427-2019-02681
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-BIOPSYFORCEPS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• 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