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

Model Number ID4030

Device Problems Deflation Problem (1149); Inflation Problem (1310); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

It was reported that during a angioplasty procedure via brachiocephalic fistula , the device was allegedly had inflation issue.It was further reported that the device allegedly had deflation issue.Reportedly, the device had incorrect, inadequate or imprecise resulted readings.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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.(expiry date: 03/2025).

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 device was returned for evaluation.During visual evaluation, no anomalies were noted to tubing and pressure gauge was securely attached.No cracks were noted to the clear plastic portion of device at pressure gauge threads.No anomalies were noted to housing, tubing, pressure gauge, handle or site gauge.During functional evaluation, the presto was connected to a pressure gauge and pressures were noted at the following atms and psi readings: 6 atm = 84psi = 5.72 atm, and 18 atm = 265psi = 18.03 atm.The presto was then used to inflate the atlas balloon it was returned with.The balloon maintained pressure and was then deflated with no issues.No further testing was performed.Therefore, the investigation is unconfirmed for the reported incorrect readings, inflation and deflation issues as the pressures noted during functional evaluation were within acceptable range of the product specification.A definitive root cause for the alleged incorrect readings, inflation and deflation issues could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 03/2025), g3, h6 (method) h11: h6 (result, conclusion) 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.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure via brachiocephalic fistula, the device allegedly had inflation issue and deflation issue.It was further reported that the device allegedly showed incorrect, inadequate or imprecise resulted readings.The procedure was completed using another 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
• Manufacturer (Section G): FOREFRONT MEDICAL TECHNOLOGY; changzhou ; CH
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15729435
• MDR Text Key: 306986139
• Report Number: 2020394-2022-00863
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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: ID2203037X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 84 KG