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.

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Another indeflator with a different lot was used to complete the procedure.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the copilot could not maintain screwing of the valve and always returned back counterclockwise.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified another copilot bleedback control valve was returned.The account confirmed another copilot was attempted to be used but the same issue of leakage occurred.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported loose/intermittent connection and the reported leak were unable to be confirmed.Device history record (dhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As the reported difficulties were unable to be confirmed during return analysis, it is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect and/or the port of the device being connected was compromised resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and the reported leak.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Additionally, 19 sterile unused devices were returned (part number: 1003331, lot 60473838).13 randomly selected units were visually inspected with no anomalies noted.All 13 units were functionally tested.All connections formed a secured connection without any anomalies.The indeflator was pressurized to 400psi with no leak noted, maintained pressure.A proxy catheter was connected to the copilot with no anomalies noted.

• 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
• 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,Followup
• Report Date: 05/28/2024

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
• 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
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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