MAUDE Adverse Event Report: NAMIC; KIT INFLATION DEVICE DIGITAL

Catalog Number	DYNJINFL8D
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Rapid jump of atmospheres of the digital inflation device.
Additional Manufacturer Narrative
It was reported that "inflation device was displaying a sudden "jump" in atmospheric pressure on the digital screen"."concerns raised by providers (techs and physicians) that it could have been causing unintentional over inflation of balloons and stent delivery systems.".It was reported that perforation occurred.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
It was originally reported that the "inflation device was displaying a sudden 'jump' in atmospheric pressure on the digital screen." it was indicated at that time that "techs were paying very close attention to the screen - the first twist to twist and a half, the device would not show any pressure, then would suddenly show numbers of 5-7." additional updates made to: e1, e2, e3.

• Common Device Name: KIT INFLATION DEVICE DIGITAL
• Manufacturer (Section D): NAMIC; 10 glens falls techincal park; glens falls NY 12801
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield; northfield, IL 60093-2753
• MDR Report Key: 21970622
• Report Number: 3015910259-2025-00041
• Device Sequence Number: 8436646
• Product Code: OEQ
• UDI-Device Identifier: 10197344110797
• UDI-Public: 10197344110797
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJINFL8D
• Device Lot Number: 2025012490
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown