MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER PEREIPHERAL DILATATION CATHETER

Model Number 1008193-30

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an unknown carotid artery. The emboshield nav6 embolic protection system (eps) was advanced to the distal end of the stenosis and it was decided by the physician to use a 5x30x135 viatrac 14 plus peripheral dilatation catheter as there was no other suitable balloon to choose during the procedure. The viatrac ruptured at 14 atmospheres and half of the balloon was withdrawn from the anatomy; however, the other half remained on the unspecified guide wire. The balloon left on the guide wire was attempted to be removed with the guiding catheter, but it would not enter the guiding catheter. A separate sheath was advanced in attempt to snare the balloon; however, was unsuccessful. Therefore, the filter and the balloon were removed together with the eps barewire. Another same size viatrac and nav6 were used to successfully complete the procedure. There was no adverse patient sequela and no clinically significant delay. No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Type of Device: PEREIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12459750
• MDR Text Key: 271015297
• Report Number: 2024168-2021-08105
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1008193-30
• Device Catalogue Number: 1008193-30
• Device Lot Number: 1033161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/13/2021 Patient Sequence Number: 1

Treatment

EMBOSHIELD NAV6