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

Model Number VA8074

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 08/19/2019

Event Type  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.Medical device - expiry date: 05/2022.

Event Description

It was reported that during an angioplasty procedure of a venous outflow graft, the pta balloon allegedly ruptured and had detached material.It was further reported that the patient required additional hospitalization to retrieve the detached material.The patient is reportedly stable post procedure.

Event Description

It was reported that during an angioplasty procedure of a venous outflow graft, the pta balloon allegedly ruptured and had detached material.It was further reported that the patient required additional hospitalization to retrieve the detached material.The patient is reportedly stable post procedure.

Manufacturer Narrative

H10: the device history records were reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned for evaluation; device evaluation confirmed detachment of the device or a device component, but was inconclusive for material rupture as the balloon portion of the device was not returned.The definitive root cause for the reported issues could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.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: (b)(6) 2022.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9009481
• MDR Text Key: 157841982
• Report Number: 2020394-2019-03271
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741121319
• UDI-Public: (01)00801741121319
• Combination Product (y/n): N
• PMA/PMN Number: K111850
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VA8074
• Device Catalogue Number: VA8074
• Device Lot Number: 93SD0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 91