MAUDE Adverse Event Report: ABBOTT VASCULAR INC. COPILOT; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number	1003331
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
User facility medwatch report received that states "patient was brought for an elective laa [left atrial appendage] occlusion device.Transseptal puncture performed.Transseptal sheath exchanged for device sheath.Device sheath uses a device called a copilot bleedback control valve.The copilot bleedback control valve was found to be defective.When blood was drawn back, the bleedback valve introduced air to the device sheath, which ultimately delivered air to the left atrium, which brought air to the coronary arteries.Troubleshooting maneuvers were performed, and st elevation resolved, with the patient eventually being sent to the icu [intensive care unit].Used a manual tuohy." subsequent to the medwatch report, it was reported that one device was in the copilot bbcv when the leak was noted.Oxygen was administered to the patient to resolve the ekg changes.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.A review of the complaint history of the reported lot revealed no similar complaints from this lot.However, the reported leak / splash issue appears to be related to a potential quality issue.The investigation determined the reported leak / splash appear to be a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
Event or Problem Description
Subsequent to the medwatch report, it was reported that one device was in the copilot bbcv when the leak was noted.Oxygen was administered to the patient to resolve the ekg changes.No additional information was provided.

• Brand Name: COPILOT
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 22234199
• Report Number: 2024168-2025-06219
• Device Sequence Number: 18416670
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: (01)08717648013997(17)260731(10)60585371
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K991102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 1003331
• Device Catalogue Number: 1003331
• Device Lot Number: 60585371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Unknown