MAUDE Adverse Event Report: CORDIS CORPORATION BIPAL; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	502402B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presented for routine endomyocardial biopsy post cardiac transplant.7f cordis 50cm biotome was used for the procedure.Right internal jugular vein (ij) access was obtained without issue.After taking first endomyocardial biopsy sample, cordis biotome could not be removed without feeling resistance.Multiple attempts were made to open biotome jaws but under fluro, the biotome jaws would not open.Finally, the biotome was successfully removed after further manipulation.Even outside the patient's body, the biotome jaws would not open or release the sample.Manufacturer response for tubing, pump, cardiopulmonary bypass, bipal (per site reporter).Awaiting a meeting.

• Brand Name: BIPAL
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 16529012
• Report Number: 16529012
• Device Sequence Number: 5410973
• Product Code: DWE
• UDI-Device Identifier: 20705032054956
• UDI-Public: (01)20705032054956
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/17/2023
• Report Date (Section F): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 502402B
• Device Catalogue Number: 502402B
• Device Lot Number: N0922314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 87 KG
• Date Report Sent to FDA: 02/17/2023