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

Model Number ID4030

Device Problems Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2018

Event Type  malfunction  

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: 03/2021).

Event Description

It was reported that during preparation for an angioplasty procedure, the inflation device allegedly had a foreign material inside.Another device was used to perform the procedure.There was no patient involvement.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.Based on the reported event details, the alleged foreign material was not identified until the device was inflated.A photo was also returned showing the alleged foreign material.However, based on the photo review and the returned sample, the material was noted to be a dislodged pressure gage filter, not foreign material.Therefore, the investigation is confirmed for a dislodged filter and is unconfirmed for the reported foreign material.It is likely that the user perceived the dislodged filter as foreign material.Based on the available information, the definitive root cause for the dislodged filter could not be determined.It is possible that inflating the device over the indicated maximum inflation pressure of 40atm could contribute to a dislodged 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.H10: d4 (expiry date: 03/2021).H11: h3, h6 (results1, conclusion1).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 preparation for an angioplasty procedure, the inflation device allegedly had a foreign material inside.Another device was used to perform the procedure.There was no patient involvement.

• Brand Name: PRESTO INFLATION DEVICE
• Type of Device: INLFATION DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8262011
• MDR Text Key: 133566899
• Report Number: 2020394-2018-02337
• 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: 10/07/2019

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: PID1803065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Manufacturer Received: 12/24/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1