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

Model Number	1003327
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the copilot did not screw in properly and leaked during the procedure.There were no adverse patient effects.A new device was used to complete the procedure.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.B3: estimated date.
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar complaints from this lot, indicating there is a potential quality issue.The investigation determined the reported loose or intermittent connection appears to be related to a potential quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.D9: correction device available for evaluation: updated from yes to no.H6: correction medical device problem code 1354 was removed.
Event or Problem Description
Subsequent to the initially filed reports, the procedure description was updated.It was reported in a general comment that the copilot did not screw in properly.There were no adverse patient effects.A new device was used to complete the procedure.There was no reported clinically significant delay in the procedure.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: 23822297
• Report Number: 2024168-2025-12105
• Device Sequence Number: 9299446
• Product Code: DTL
• UDI-Device Identifier: 08717648013973
• UDI-Public: (01)08717648013973(17)270630(10)60660879
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 60660879
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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