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

Catalog Number ID4030

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

No medical records or images have been made available to the manufacturer.The lot number for the device has been provided.A review of the device history records is currently being performed.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 the pressure gauge on the inflation device allegedly did not read pressure during the initial inflation.Reportedly, another inflation device was used to complete the procedure.There was no reported impact or consequence to the patient.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records were reviewed.The lot met all release criteria meaning that no issues were noted during the manufacturing process or quality control inspections.However, two internal rejects were found to have gauge accuracy issues, these rejects could be related to the reported event.Therefore, this could be a manufacturing related issue.Visual/microscopic inspection: the device was returned.There were no cracks identified on the device.Tubing was not kinked.No anomalies identified with the quick release button.Pressure gauge aligned with zero.Functional/performance evaluation: the device was filled with water for functional testing.The device was purged of any air then attached to an in-house pressure gauge.The handle was rotated slowly increasing the pressure of the device.It was noted that the pressure gauge on the device did not show an increase in pressure at the same rate as the in-house pressure gauge.The handle was rotated at an increased speed increasing the pressure in the device.It was noted that a delay in the pressure gauge on the device could be noticed at the increased speed.The pressure gauge of the device was removed and examined under black light.Excess glue could be seen in the filter of the pressure gauge.No anomalies were noted to the other components of the device.Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: the investigation is confirmed for the device operating differently than expected, as the excess glue found on the filter of the pressure gauge led to the gauge not operating correctly.Labeling review: the current ifu (instructions for use) state: precautions: 1.Carefully inspect the device prior to use to verify that it has not been damaged during shipment.Do not use if device damage is evident.2.Discontinue use of the device if damage, malfunction or contamination is suspected during use.3.For experienced physician use only.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.

• Brand Name: PRESTO INFLATION DEVICE
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FOREFRONT MEDICAL TECHNOLOGY; changzhou ; CH
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5132287
• MDR Text Key: 27983353
• Report Number: 2020394-2015-01678
• Device Sequence Number: 1
• Product Code: MAV
• 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: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Catalogue Number: ID4030
• Device Lot Number: PID1505018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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