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

Model Number VA80104

Device Problems Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The return of the device is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure in venous anastomosis, the pta balloon allegedly ruptured and had detached material.It was further reported that a cut-down procedure was done to remove the detached material.Another device was used to complete the procedure.No further treatment was needed.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: a segment of the device was returned for evaluation.A visual inspection found a complete detachment of the inner guidewire lumen as well as a complete detachment of the balloon at a complete compound balloon rupture.Therefore, the investigation is confirmed for balloon and catheter detachments, as well as for a compound balloon rupture.The returned portion of the balloon was still attached at the distal balloon joint.However, the balloon material was returned prolapsed over the distal tip.Based on the prolapsed balloon material and detached components, the investigation is confirmed for retraction issues.It is likely that the rupture contributed to the identified retraction issues and detachments.However, the definitive root cause for the identified issues could not be determined based on the available information.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.

Event Description

It was reported that during an angioplasty procedure in venous anastomosis, the pta balloon allegedly ruptured and had detached material.It was further reported that a surgical procedure was done to remove the detached material.Another device was used to complete the procedure.No further treatment was needed.

• 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: 8180207
• MDR Text Key: 130883458
• Report Number: 2020394-2018-02222
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VA80104
• Device Catalogue Number: VA80104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR