MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Copilot; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Model Number	1003331
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction

• 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 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 25909754
• Report Number: 2024168-2026-02904
• Device Sequence Number: 12864820
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: (01)08717648013997(17)270831(10)60676848
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1003331
• Device Catalogue Number: 1003331
• Device Lot Number: 60676848
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• 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
• Patient Sex: Unknown