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

Model Number	1000184
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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 specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.It is possible inadvertent mishandling resulted in the reported gauge break however, as the device was not returned for analysis the investigation determined a conclusive cause for the reported difficulty cannot be determined.Based on the 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.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and tortuous lesion in the right coronary artery (rca).A 20/30 indeflator was attempted to be used however the pressure gauge was noted to not increase when inflating the connected device.Therefore the indeflator was replaced with a new 20/30 indeflator and the procedure was completed.There were no adverse patient effects nor clinical delay.No additional information was provided.

• 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: 21644844
• Report Number: 2024168-2025-02858
• Device Sequence Number: 7700465
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: (01)08717648013591(17)250228(10)60440894
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/19/2025

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: 02/28/2025
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60440894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2023
• 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