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

Model Number 1003331

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

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

Event Date 12/19/2022

Event Type  malfunction  

Event Description

It was reported that during preparation, a three-way stopcock was attempted to be connected to the port of the copilot bleed back control valve (bbcv); however, a good connection could not be secured, and the stopcock was not connected.There was no patient involvement and no clinically significant delay in the procedure.Returned device analysis identified that fluid was observed leaking from a crack on the middle portion of the rotator distal to the o-ring.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported loose or intermittent connection was unable to be confirmed.Additionally, breaks (longitudinal crack on the body of the copilot, a crack on the middle portion of the rotator) and a leak was noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.As the reported difficulties were unable to be confirmed during return analysis, it is possible that the device was not fully connected/tightened resulting in the reported loose/intermittent connection; however this cannot be confirmed.The investigation determined a conclusive cause for the reported loose/intermittent connection cannot be determined.The noted breaks (longitudinal crack on the body of the copilot, crack on the middle portion of the rotator) and the noted leak possibly occurred as a result of inadvertent mishandling during attempts to connect the devices and/or during shipment back for return analysis; however this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 16401693
• MDR Text Key: 309892538
• Report Number: 2024168-2023-01642
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: 08717648013997
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 1003331
• Device Catalogue Number: 1003331
• Device Lot Number: 60362233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2022
• 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