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

Model Number	1000184
Medical Device Problem Codes	Leak/Splash (1354); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
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.As the device was not returned for analysis, the investigation determined a conclusive cause for the reported difficulties 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 the procedure was to treat a lesion in the proximal right coronary artery (rca).A non-abbott stent was deployed in the proximal rca with the indeflator.Residual stenosis proximal to the first stent was noted; therefore, another non-abbott stent was advanced and placed in the target lesion.The physician noticed that the indeflator need more rotation than usual to achieve pressure gauge movement.The device was inflated to 18 atmospheres (atm) when it was noted there was half contrast half air filled in the balloon while inflation.The balloon was deflated and the system was pulled out; however, the stent dislodged in the ostial rca.The physician suspected the indeflator did not work properly therefore a non-abbott indeflator was used to achieve apposition of the dislodged stent at ostial rca.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 21942169
• Report Number: 2024168-2025-04528
• Device Sequence Number: 12857560
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: (01)08717648013591(17)241130(10)60418863
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K961471
• 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): 05/01/2025

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: 11/30/2024
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60418863
• 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: 04/21/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2022
• 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: SUPRAFLEX CRUZ 4.5X24 MM; SUPRAFLEX CRUZ 4.5X8 MM
• Patient Sex: Unknown