MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Presto Inflation Device

Catalog Number	ID4030
Medical Device Problem Codes	Decoupling (1145); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2026, a patient underwent an angioplasty procedure using a pta balloon and a presto inflation device.During the procedure, the three way valve became loose while under pressure.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one presto inflation device was returned for evaluation.The luer assembly was noted to be detached, with the threaded portion of the luer not returned for evaluation.The plastic ring portion of the luer was loose on the device, and able to be slid freely on the tubing.A 3-way valve was also returned for evaluation.The returned 3-way valve was connected to an in-house pressure gauge and attempted to be tested.However, upon inflation attempt no fluid was observed going through the valve.Under microscopic evaluation, dried saline was noted to be present within in 3-way valve.No further functional testing was able to be performed.Therefore, the investigation is inconclusive for the reported disconnecting, as the 3-way valve was unable to be functionally tested.The investigation is confirmed for the identified detachment, as the luer assembly was noted to be detached on the returned sample.It is unknown the relationship between the identified detachment and reported disconnection from the device.The definitive root cause for the reported event could not be determined based upon available 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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50850442
• Report Number: 2020394-2026-02783
• Device Sequence Number: 13275143
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• 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
• Report Date (Section B): 09/18/2026

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: ID2507129X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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