MAUDE Adverse Event Report: CORDIS US. CORP BIOPSY FORCEP; DEVICE, BIOPSY, ENDOMYOCARDIAL

Catalog Number	504302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, there was a death during a myocardial biopsy procedure while using the 5.5f biopsy forceps.The patient was at higher risk due to sampling closer to the apex of the heart, cardiac tamponade developed during sampling and the patient died.It was reported there was an operational error on the part of the doctor in charge.A non-cordis sheath listed as a concomitant device; however, it was reported to ¿not be clinically used¿.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was a death during a myocardial biopsy procedure while using the 5.5f biopsy forceps.The patient was at higher risk due to sampling closer to the apex of the heart, cardiac tamponade developed during sampling and the patient died.It was reported there was an operational error on the part of the doctor in charge.A non-cordis sheath was used during the procedure.The device was properly, managed in the medical equipment storeroom in the operating room.There were no anomalies noted when the device was taken out of the package.The device removed from the tray in a horizontal motion.It was noted that there was an attempt made to shape the shaft or the tip.The physician noted that this procedure was high-risk.The device will not be returned for evaluation.
Additional Manufacturer Narrative
As reported, there was a death during a myocardial biopsy procedure while using the 5.5f biopsy forceps.The patient was at higher risk due to sampling closer to the apex of the heart, cardiac tamponade developed during sampling and the patient died.It was reported there was an operational error on the part of the doctor in charge.A non-cordis sheath was used during the procedure.The device was properly, managed in the medical equipment storeroom in the operating room.There were no anomalies noted when the device was taken out of the package.The device was removed from the tray in a horizontal motion.It was noted that there was an attempt made to shape the shaft or the tip.The physician noted that this procedure was high-risk.The device was not returned for evaluation.Without the return of the device or images for analysis, it cannot be confirmed if the event ¿cardiac tamponade¿ is related to manufacturing or design issues.Procedural factors may have contributed to the reported event as it was reported the doctor in charge made an operational error.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿this product is intended for use by professionals who have been trained to perform endomyocardial biopsies.Complications 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: arteriovenous fistula formation, bleeding and/or hematoma at the puncture site, death, embolism, infection, lesions of the tricuspid valve, nerve injury, perforation of the vessel wall or the myocardium, pneumothorax, thrombosis, various types of arrythmias, vessel trauma.Note: these biopsy forceps are not formable.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: BIOPSY FORCEP
• Common Device Name: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 45 lexington drive; laconia, new hampshire 03246 ; 7863138372
• MDR Report Key: 19562710
• Report Number: 1016427-2024-00015
• Device Sequence Number: 18032428
• Product Code: DWZ
• UDI-Device Identifier: 10705032056113
• UDI-Public: 10705032056113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Catalogue Number: 504302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/16/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDIKIT SHEATH.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown