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

Catalog Number ID4030

Device Problems Break (1069); Leak/Splash (1354); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not 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.

Event Description

It was reported that during an angioplasty procedure, the inflation device could not inflate past 25 atm.It was further reported that the device had a break.There was no reported patient injury.

Manufacturer Narrative

This supplemental emdr is being submitted to report the change in reportability, due to information received on 1/21/2019.As the lot number for the device was not provided, a manufacturing review could not 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.

Event Description

It was reported that during an angioplasty procedure, the inflation device allegedly leaked.There was no reported patient injury.

• 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: 8255150
• MDR Text Key: 133326649
• Report Number: 2020394-2018-02326
• 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: 02/14/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: ID4030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1