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

Catalog Number ID4030

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of 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 bard.

Event Description

It was reported that during an angioplasty procedure, the pressure gauge of the inflation device allegedly would not indicate an increase in pressure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.An initial visual inspection did not find any anomalies with the device.The device syringe was filled with water and connected to an in-house pressure gauge.The device was slowly pressurized by rotating the handle.The in-house pressure gauge increased as the handle was rotated, however the presto gauge did not initially increase with the applied pressure.Subsequent attempts resulted in the presto pressure gauge increasing to 2atm and 17atm respectively.Neither of these pressure readings were representative of the actual pressure applied by the device.Therefore, the investigation is confirmed for the reported pressure gauge issue.Based on the evaluation of the returned device, glue was found partially covering the pressure gauge filter.Functional testing with water resulted in lower than expected pressure indicated on the gauge.It should be noted that all presto inflation devices are pressure tested at the manufacturing site using air not water.The definitive root cause for the differences in pressure noted during functional testing could not be determined based on the available information.However, it is likely due to the presence of glue on the gauge filter.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that during an angioplasty procedure, the pressure gauge of the inflation device allegedly would not indicate an increase in pressure.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: 7648288
• MDR Text Key: 112716234
• Report Number: 2020394-2018-01012
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• 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: PID1711229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 62