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

Model Number 502402B

Device Problems Entrapment of Device (1212); Mechanical Jam (2983)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/15/2022

Event Type  Injury  

Event Description

Patient undergoing right heart cath with multiple myocardial biopsies.Biopsy forceps tested prior to use, was functioning appropriately.Two biopsies were obtained without difficulty.The third biopsy sample was obtained, the locking mechanism would not release the forceps.The patient required transfer to the or for removal.Two attempts to release the locking mechanism were made by cutting the coaxial cable which were unsuccessful.The forceps had to be pulled from the myocardial tissue causing a portion of the myocardium to be extracted with the forceps leading to a pericardial effusion.

Event Description

Patient undergoing right heart cath with multiple myocardial biopsies.Biopsy forceps tested prior to use, was functioning appropriately.Two biopsies were obtained without difficulty.The third biopsy sample was obtained, the locking mechanism would not release the forceps.The patient required transfer to the or for removal.Two attempts to release the locking mechanism were made by cutting the coaxial cable which were unsuccessful.The forceps had to be pulled from the myocardial tissue causing a portion of the myocardium to be extracted with the forceps leading to a pericardial effusion.

• Brand Name: BIPAL
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 15923739
• MDR Text Key: 304890744
• Report Number: 15923739
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 502402B
• Device Catalogue Number: 502402B
• Device Lot Number: N0622305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2022
• Device Age: 0 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 18980 DA
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White