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

Catalog Number	ID4030
Medical Device Problem Codes	Crack (1135); Inflation Problem (1310); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the device pressure was increased but the pressure suddenly got decreased in the middle of the procedure.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 returned for evaluation connected to a boston scientific athletis balloon.Unknown liquid was noted in the device.The unknown liquid was flushed from the presto device.The presto device was then filled with water and an attempt was made to inflate the balloon.Water was noted leaking at the 3-way stopcock.Under microscopic observation, a crack was noted at the 3-way stopcock.The 3-way stopcock was removed from the presto device.The presto device was then connected to an in-house pressure gauge, the piston handle was turned to read 8 atm and 12 atm.The psi reading on the pressure gauge remained at 0.No other functional testing was performed.Therefore, the investigation is confirmed for the reported inflation issue as water was noted leaking from a crack at the 3-way stopcock during inflation, and after the cracked stopcock was replaced, the psi reading remained at zero when the atm was increased.Thus, the investigation is also confirmed for the identified crack on stopcock and incorrect pressure gauge reading.A definitive root cause for the alleged inflation issue, identified crack on stopcock and incorrect pressure gauge reading 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.H10: d4 (expiration date: 10/2025).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.

• 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: 19200179
• Report Number: 2020394-2024-00576
• Device Sequence Number: 18151293
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: ID2210184X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/29/2024
• 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