MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PRESTO INFLATION DEVICE

Catalog Number	ID4030
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one presto inflation device was returned for evaluation.Upon visual inspection, it was noted the toggle lever was depressed and would not reset to upright position.Liquid was noted within the syringe.A stopcock was returned connected to the luer of the device.During functional testing, the luer of the high pressure tubing along the stopcock was placed in water and the piston handle was pulled all the way proximally and stayed in place.The toggle button remained depressed but then reverted to upright position once the handle was slightly pushed forward.Water was aspirated into the syringe without issues.The returned cockstop and luer of the presto high pressure tubing and turned to the off position to prevent water from exiting.Then the piston handle was turned to build up the pressure.Pressure was increased as shown in the gauge, however a second increase in the pressure made the presto lose pressure.The gauge went to 0 atm, and it was noted, water was leaking from the brass fitting behind the gauge.In addition, water entered the pressure gauge.No other functional testing was performed.Therefore, the investigation is confirmed for the reported incorrect, inadequate or imprecise result or readings and identified leak as the water was leaking from the brass fitting behind the pressure gauge, which could have caused the pressure gauge malfunction.A definitive root cause for the reported pressure gauge not working and identified leak could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.Section a through f: the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent percutaneous transluminal angioplasty (pta) procedure using the presto inflation device.During the procedure, the gauge allegedly not working.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: PRESTO INFLATION DEVICE
• Common Device Name: INFLATION DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FOREFRONT MEDICAL TECHNOLOGY; changzhou ; CH
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24603572
• Report Number: 2020394-2026-00653
• Device Sequence Number: 18231401
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009(17)271112(10)ID2411156X
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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 Catalogue Number: ID4030
• Device Lot Number: ID2411156X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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