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

Catalog Number	ID4030
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent an angioplasty procedure using a presto inflation device and a pta balloon.During the procedure, it was reported that the balloon could not be fully deflated and, as a result, could not be withdrawn through the sheath.The procedure was subsequently completed using another inflation device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: e1 (b)(6).H.4.Device manufacture date: unknown.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported deflation problem 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 provide by bd represents all 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: 50730812
• Report Number: 2020394-2026-02526
• Device Sequence Number: 10586837
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009(17)280721(10)ID2507151X
• 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): 09/03/2026

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: ID2507151X
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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