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

Model Number	1003327
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the copilot valve does not connect to the acist kit injection system faucet.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.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 returned for analysis.The reported loose or intermittent connection was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed an indication of a product quality issue.A review of the complaint history of the reported lot revealed no similar complaints from this lot.However, further investigation was initiated to evaluate the copilot complaint regarding the reported loose or intermittent connection issues.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.D1: correction: brand name updated.D2a: correction: common device name updated.D2b: correction: procode updated.
Event or Problem Description
Subsequent to the initially filed reports, an additional copilot was received.The device showed signs of use and failed to maintain a secure connection during functional testing.The account did not report any issues with this device.No additional information was provided.

• Brand Name: INDEFLATOR
• 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: 24495476
• Report Number: 2024168-2026-00862
• Device Sequence Number: 21492176
• Product Code: DTL
• UDI-Device Identifier: 08717648013973
• UDI-Public: (01)08717648013973(17)271130(10)60699775
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60699775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACIST KIT.
• Patient Sex: Unknown