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

Catalog Number	ID4030
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2026).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure via iliac stenosis, the pressure gauge in the device was allegedly not working.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 received for evaluation.On visual analysis, the sample was received with a 3 way stop cock loaded onto the luer connector and the pressure gauge was at 0 atm.No other anomalies were observed.On functional testing, an in-house pressure gauge was connected with the returned presto device and the piston was turned to various pressure levels.The pressure gauge on the device provided readings within the acceptable product specifications compared to the in-house pressure gauge.The pressures were noted at the following atms and psi readings: 8 atm = 127 psi = 8.65 atm, 12 atm = 178 psi = 12.11 atm, 14 atm = 210 psi = 14.29 atm.Therefore, the investigation is unconfirmed for the reported pressure gauge not working issue as the sample presto device showed correct reading during functional testing, which matched with in-house pressure gauge readings and it was within the acceptable limits.A definitive root cause for the reported pressure gauge not working issue 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.H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that prior to an angioplasty procedure via iliac stenosis, the pressure gauge in the device was allegedly not working.The procedure was completed using another device.There was no patient contact.

• 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: 19818961
• Report Number: 2020394-2024-01048
• Device Sequence Number: 18338056
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009(17)261126(10)ID2311147X
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: ID2311147X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/23/2024
• 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