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	Perforation of Vessels (2135)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an angioplasty procedure, when inflating the balloon, the presto inflator pointer allegedly vibrated at a rate of 1 to 2 atm.It was further reported that the surgeon thought the pressure had not been reached and continued to inflate, causing the balloon to rupture.Furthermore, the patient's blood vessels were also allegedly ruptured.Evidently, the surgeon used a new balloon to stop vessel bleeding.The patient is reported to be stable now.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2026).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.
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: the physical device was not returned for evaluation.One photo was provided and reviewed.The photo shows two presto devices connected to a three-way stopcock.User confirmed the presto device seen on the left is for this record.The pressure gauge is pointing off of zero, but since the device is connected, it is not possible to confirm that this was not pressurized.No specific anomalies noted.Therefore, the investigation is inconclusive for the reported incorrect reading as no objective evidence is provided.A definitive root cause for the alleged incorrect 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.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, when inflating the balloon, the inflator pointer allegedly vibrated at a rate of 1 to 2 atm.It was further reported that the surgeon thought the pressure had not been reached and continued to inflate, causing the balloon to rupture.Furthermore, the patient's blood vessels were also allegedly ruptured.Evidently, the surgeon used a new balloon to stop vessel bleeding.The patient is reported to be stable now.

• 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: 20044937
• Report Number: 2020394-2024-01274
• Device Sequence Number: 7998401
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009(17)261022(10)ID2310123X
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ID4030
• Device Lot Number: ID2310123X
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown