MAUDE Adverse Event Report: CORDIS US. CORP BF BIPAL 7F 50CM 2.2MM JAW; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	502402B
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during the use of a 7f 50cm 2.2mm jaw bipal biopsy forceps, the jaws of the device were unable to open and release from the right ventricle when attempting to collect a myocardial biopsy sample.As a result, the patient was taken to surgery to remove the device.This was during a myocardial biopsy procedure.There were no issues obtaining vascular access, and the access vessel did not have any calcification or tortuosity present.The device was stored, handled, and prepped pe the instructions for use (ifu).The device was removed from its tray in a horizontal motion and there was never an attempt to shape the tip of the device.There was no difficulty tracking the device towards the target area.The device will 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, during the use of a 7f 50cm 2.2mm jaw bipal biopsy forceps, the jaws of the device were unable to open and release from the right ventricle when attempting to collect a myocardial biopsy sample.As a result, the patient was taken to surgery to remove the device.This was during a myocardial biopsy procedure.There were no issues obtaining vascular access, and the access vessel did not have any calcification or tortuosity present.The device was stored, handled, and prepped pe the instructions for use (ifu).The device was removed from its tray in a horizontal motion and there was never an attempt to shape the tip of the device.There was no difficulty tracking the device towards the target area.The device was not retuned as expected.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b1, b2, b5, d4, d9, g3, g6, h1, h2, h3, h6, and h10.A review of the manufacturing documentation associated with lot n0922314 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, during the use of a 7f 50cm 2.2mm jaw bipal biopsy forceps, the jaws of the device were unable to open and release from the right ventricle when attempting to collect a myocardial biopsy sample.As a result, the patient was taken to surgery to remove the device.This was during a myocardial biopsy procedure.There were no issues obtaining vascular access, and the access vessel did not have any calcification or tortuosity present.The device was stored, handled, and prepped pe the instructions for use (ifu).The device was removed from its tray in a horizontal motion and there was never an attempt to shape the tip of the device.There was no difficulty tracking the device towards the target area.The device was not returned for analysis.A product history record (phr) review of lot n0922314 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿jaws-open/close difficulty¿ and ¿biopsy forceps-withdrawal difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue experienced by the customer could not be determined.Based on the information available for review, procedural/handling factors may have contributed to the issue reported as damage to the biopsy forceps can impair the opening/closing function of the jaws.As standard use of the device, it is recommended to check if the jaws of the biopsy forceps are opening and closing properly prior to use in the patient.As cautioned by the instructions for use, which is not intended as a mitigation, ¿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.¿ neither the phr review nor the information available suggests a design or manufacturing-related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.H3 other text: device not returned.

• Brand Name: BF BIPAL 7F 50CM 2.2MM JAW
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• 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 ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16526444
• Report Number: 1016427-2023-05443
• Device Sequence Number: 2620060
• Product Code: DWE
• UDI-Device Identifier: 20705032054956
• UDI-Public: (01)20705032054956(17)250831(10)N0922314
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 502402B
• Device Catalogue Number: 502402B
• Device Lot Number: N0922314
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 04/13/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/12/2023; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 103 KG