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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER PEREIPHERAL DILATATION CATHETER Back to Search Results
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 The viatrac ruptured at 14 atmospheres and half of the balloon was withdrawn from the anatomy; however, the other half remained on the unspecified guide wire.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.
 
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Brand NameRX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
Type of DevicePEREIPHERAL 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 Key12459750
MDR Text Key271015297
Report Number2024168-2021-08105
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K072798
Number of Events Reported1
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 Received09/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1008193-30
Device Catalogue Number1008193-30
Device Lot Number1033161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2021
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
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