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

Model Number ID4030

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure, the pressure gauge of the inflation device allegedly failed to work.There was no reported patient injury.

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 devices has returned for evaluation, on the visual evaluation of the device it appeared to contain some saline residue and liquid in the chamber and the piston had fully retracted.On the functional evaluation of the device, the button toggled easily and liquid in the chamber has cleared out.Then by using the returned valve the liquid has filled and it has noted the pressure raised on the inflation device and the gauge needle would go up.On upon depressurize the chamber the gauge needle moved slowly to 0 atm and found stuck.Then the inflation device has connected to pressure gauge and the piston get twisted to reach 8 atm and the pressure on the pressure gauge has noted at 8 atm.Then the button in the presto device toggled and the needle returned to 0 atm slowly and stuck at 4 atm.Therefore, the reported pressure gauge failed to work was confirmed as the needle of presto devices got stuck and moves slowly while depressurizing the device back to 0 atm.A definitive root cause for the alleged pressure gauge failed to work could not be determined based upon the provided 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: b5, d4 (expiry date: 03/2023), g3.H11: d4 (medical device lot), h6 (method, result, conclusion).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.

Event Description

It was reported that during an angioplasty procedure, the pressure gauge of the inflation device allegedly failed to work.The procedure was completed using same device.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: 10956656
• MDR Text Key: 219917343
• Report Number: 2020394-2020-20756
• 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: 03/30/2021

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 Model Number: ID4030
• Device Catalogue Number: ID4030
• Device Lot Number: PID2003005X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other