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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 1008197-20
Device Problems Off-Label Use (1494); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history revealed no other similar incidents reported for this lot. It should be noted that per instructions for use (ifu), the, viatrac 14 plus, global ce, states: the viatrac 14 plus peripheral dilatation catheter is intended to dilate stenosis in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries), and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In this case, use of the device in the wrong anatomy does not appear to have caused or contributed to the reported balloon rupture. The device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use. The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure. In this case, it is likely that during advancement though the heavily tortuous and heavily calcified anatomy, the balloon outer surface became damaged resulting in the reported balloon rupture during the first inflation. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The other rx viatrac balloon dilatation catheter referenced is filed under separate a medwatch report number.
 
Event Description
It was reported that two viatrac balloon dilatation catheters were prepared without issue. During a heavily tortuous and calcified right internal carotid intervention, both balloons ruptured during the first inflation below the rated burst pressure. Two xact stent systems were advanced, but failed to cross due to the heavily calcified anatomy. The procedure was completed with another rx viatrac plus 6x30 that was able to open up the lesion. There was no adverse patient effect 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 Key11043508
MDR Text Key230339934
Report Number2024168-2020-10752
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072798
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1008197-20
Device Catalogue Number1008197-20
Device Lot Number0093061
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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