MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VIDA PTV CATHETER; PTA DILATATION BALLOON CATHETER

Catalog Number VDA100166

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted as the lot number is unknown.Visual inspection: as the sample was not returned for evaluation, a visual inspection could not be performed.Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current vida ptv catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.

Event Description

It was reported that while treating a venous anastomosis the pta balloon allegedly ruptured at 12 atm on the first inflation.Reportedly, there was no retraction issues.There was no additional treatment provided.There was no reported patient injury.

• Brand Name: VIDA PTV CATHETER
• Type of Device: PTA DILATATION BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5629449
• MDR Text Key: 44339976
• Report Number: 2020394-2016-00420
• Device Sequence Number: 1
• Product Code: OMZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131002
• 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: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VDA100166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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