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 Death (1802)

Event Date 09/19/2019

Event Type  Death  

Manufacturer Narrative

The lot number of the device was provided.The device history records are currently under review.The return of the sample is pending.The investigation is currently underway.(expiry date: 06/2020).

Event Description

It was reported that during an angioplasty procedure in the iliac vein, the monometer was allegedly not working.It was reported that the procedure was completed with the same device but no dial to determine the atms.It was further reported that the patient expired from a pulmonary embolism.

Manufacturer Narrative

H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection was performed and no anomalies were noted to the device.The device was connected to an in house pressure gauge and attempted to be pressurized.The pressure was increased but the pressure gauge on the device remained at 0.No glue was seen blocking the pressure gauge.Therefore, the investigation is confirmed for the reported pressure gauge issue, as the pressure gauge would not increase when the device was under pressure.The definitive root cause for the reported pressure gauge issue could not be determined based upon available information.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.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during an angioplasty procedure in the iliac vein, the monometer was allegedly not working.It was reported that the procedure was completed with the same device but no dial to determine the atms.It was further reported that the patient expired from a pulmonary embolism.

• 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: 9199710
• MDR Text Key: 162612296
• Report Number: 2020394-2019-04026
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: ID4030
• Device Catalogue Number: ID4030
• Device Lot Number: PID1906076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 89 YR
• Patient Weight: 68