MAUDE Adverse Event Report: ABBOTT VASCULAR COPILOT® BLEEDBACK CONTROL VALVE; ACCESSORIES

Catalog Number 1003331

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The copilot was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Another copilot was attempted to be used but also could not maintain screwing of the valve and always returned back counterclockwise.Another copilot with a different lot was used to complete the procedure.There was no adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional copilot device referenced in b5 is filed under a separate medwatch report number.

• Brand Name: COPILOT® BLEEDBACK CONTROL VALVE
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19068173
• MDR Text Key: 339789982
• Report Number: 2024168-2024-04443
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: (01)08717648013997(17)250531(10)60473838
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1003331
• Device Lot Number: 60473838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1