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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR RX VIATRAC PLUS PEREIPHERAL DILATATION CATHETER Back to Search Results
Model Number 1008195-40
Device Problems Off-Label Use (1494); Material Rupture (1546); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was not returned 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 identified no other complaints. It should be noted that the indication for use listed in the viatrac plus instruction for use 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). In this case, it could not be determined if the off-label use caused or contributed to the reported difficulties. Based on the information provided, a definitive cause for the reported balloon rupture and separation could not be determined. It may be possible that the rupture occurred due to interaction with lesion calcification or associated devices. Additionally, the separation may have occurred during removal due to the ruptured balloon material catching on the introducer sheath; however, this could not be confirmed. The additional treatment to snare the separated portion of the balloon was due to case circumstances. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the carotid artery. A 5. 5x40mm viatrac plus peripheral dilatation catheter ruptured during the first inflation at 8 atmospheres and the balloon separated. The separated balloon piece was snared out and the procedure was successfully completed. There were no adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameRX VIATRAC PLUS
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 Key9975025
MDR Text Key188369573
Report Number2024168-2020-03737
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 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model Number1008195-40
Device Catalogue Number1008195-40
Device Lot Number9040861
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 Received03/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2019
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: 04/17/2020 Patient Sequence Number: 1
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