MAUDE Adverse Event Report: ABBOTT VASCULAR INC. INDEFLATOR; SYRINGE, BALLOON INFLATION

Model Number	1000186
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified circumflex artery.The 20/30 indeflator began to lose pressure once it reached to 12 atmospheres during the procedure.Another device was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.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.Device history record (dhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot of level product quality issue.It is possible that the connection port was not fully connected/tightened and/or the device being connected was compromised thus resulting in the reported leak difficulties; however, as the device was not returned for analysis this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported leak difficulties.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D1 correction: brand name updated d2a correction: common device name updated d3 correction: name, address updated.

• Brand Name: INDEFLATOR
• Common Device Name: SYRINGE, BALLOON INFLATION
• 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: 19097176
• Report Number: 2024168-2024-04614
• Device Sequence Number: 7268344
• Product Code: MAV
• UDI-Device Identifier: 08717648013614
• UDI-Public: (01)08717648013614(17)250831(10)60498707
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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): 08/19/2024

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: 08/31/2025
• Device Model Number: 1000186
• Device Catalogue Number: 1000186
• Device Lot Number: 60498707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2023
• 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
• Patient Sex: Unknown