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

Model Number 1003331

Device Problems Leak/Splash (1354); Difficult to Advance (2920)

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

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a right coronary artery (rca).The copilot met resistance when delivering device (unspecified balloon).When inflating the unspecified balloon there was pressure build up and when pressure was released blood was noted to be leaking from the bleedback control seal of the copilot.Another copilot was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 identified no other incidents from this lot.13 sterile/ unused devices were received.On the pouch label: copilot bleedback control valve part#1003331 lot#60362223.All 13 sterile/unused devices were visually inspected and there was no damage noted to the sterile/unused devices.Testing was successfully performed on the returned 13 sterile/unused devices with no issue noted.There was no leak noted at the returned copilot.It is possible that the devices were not coaxially aligned during insertion thus resulting in the reported difficult to advance; however this cannot be confirmed.Additionally, it is possible the cap seal was not fully tightened/closed resulting in the reported leak; however this cannot be confirmed the investigation was unable to determine a conclusive cause for the reported difficulties.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: 14824220
• MDR Text Key: 295487389
• Report Number: 2024168-2022-06860
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: 08717648013997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2022
• 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: 60362223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 78 KG