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

Model Number ID4030

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 12/2022).

Event Description

It was reported that during an angioplasty procedure, the pressure gauge of the inflation device allegedly showed incorrect pressure value.It was further reported that the balloon allegedly exploded.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the pressure gauge of the inflation device allegedly showing incorrect pressure value.It was further reported that the balloon allegedly exploded.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: four devices were returned for evaluation.A visual inspection was performed and no anomalies were noted to the devices.For each device, the button was able to be easily toggled.The button was pushed and the piston was attempted to be retracted and moved freely.Three of the devices were able to be inflated to nominal pressure and the pressure gauge was noted to hold the correct pressure.However, when inflating the fourth sample the pressure gauge was noted to fluctuate and the correct pressure was not being held.No further testing was conducted.Therefore, the investigation is confirmed for the reported incorrect pressure gauge reading, as one of the devices was noted to show incorrect pressure reading during evaluation.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 12/2022).H11: 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.H3 other text : see h10.

• Brand Name: PRESTO INFLATION DEVICE
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10933600
• MDR Text Key: 219132371
• Report Number: 2020394-2020-20727
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009
• Combination Product (y/n): N
• PMA/PMN Number: K143522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ID4030
• Device Catalogue Number: ID4030
• Device Lot Number: PID1912167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other