MAUDE Adverse Event Report: CORDIS CORPORATION BIOPSY FORCEPS 5.5F STD 104CM; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number	504300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint conclusion: while using a 5.5f 104cm standard biopsy forceps, the right atrium was perforated.Conservative therapy was taken, and the patient has been followed up.Additional information was requested but was not available.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿atrial perforation¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown.As no lot number was supplied a phr could not be completed.According to the safety information in the instructions for use ¿the cordis biopsy forceps are designed for endomyocardial biopsies.If strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the forceps.Possible complications include, but are not limited to: perforation of the vessel wall or the myocardium.¿ the information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, while using a 5.5f 104cm standard biopsy forceps, the right atrium was perforated.Conservative therapy was taken, and the patient has been followed up.Additional information was requested but was not available.The device was discarded and will not be returned.

• Brand Name: BIOPSY FORCEPS 5.5F STD 104CM
• Common Device Name: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15451257
• Report Number: 1016427-2022-05421
• Device Sequence Number: 5672981
• Product Code: DWZ
• UDI-Device Identifier: 10705032056090
• UDI-Public: 10705032056090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K933235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: 504300
• Device Catalogue Number: 504300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown