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

Model Number	1000186
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that a procedure was performed to treat a lesion in an unknown vessel.A 20/30 indeflator priority pack accessory kit (ppak), was attempted to be used to inflate an unknown balloon; however, the gauge did not provide atmospheres and the balloon could not be inflated.The indeflator was replaced with another syringe device and the procedure was completed.There were no adverse effects nor clinical delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported leak and the reported gauge break were able to be confirmed.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 one other similar incident from this lot.The investigation determined the reported/noted difficulties appear 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.H6 correction: medical device problem code 1069 added.

• 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: 21345267
• Report Number: 2024168-2025-01458
• Device Sequence Number: 21070434
• Product Code: MAV
• UDI-Device Identifier: 08717648013614
• UDI-Public: (01)08717648013614(17)260228(10)60546933
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 09/19/2025

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: 02/28/2026
• Device Model Number: 1000186
• Device Catalogue Number: 1000186
• Device Lot Number: 60546933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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