MAUDE Adverse Event Report: ABBOTT VASCULAR INC. INDEFLATOR; ACCESSORIES

Model Number	1000184
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, moderately tortuous left circumflex artery.When attempting to inflate a 2.0 x 15 mm non-abbott balloon using a 20/30 indeflator the pressure gauge would not increase and a water leak from the indeflator was observed within the pressure gauge.A new 20/30 indeflator was used to successfully complete the procedure.There was no adverse patient effects and no 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 not returned for analysis.Production record and corrective and preventive actions (capa) reviews were performed and revealed an indication of a product quality issue.Additionally, a review of the complaint handling database identified five other similar incidents from this lot.The investigation determined the reported leak appears to be a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: INDEFLATOR
• Common Device Name: ACCESSORIES
• 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: 20776352
• Report Number: 2024168-2024-13935
• Device Sequence Number: 4399755
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: (01)08717648013591(17)250731(10)60488528
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 01/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60488528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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: 2.0 X 15 MM NC SPRINTER BALLOON
• Patient Sex: Unknown