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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1008197-20
Device Problems Off-Label Use; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress
Event Date 03/01/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was received. Investigation is not yet completed. A follow up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the procedure was to treat a mildly tortuous and moderately calcified right carotid artery in the carotid siphon area. A 6. 0 x 20 mm viatrac plus peripheral dilatation catheter was used; however, a kink in the shaft was noted during unpacking. Therefore, the device failed to cross the lesion and was replaced with a 4. 0 x 20 mm trek balloon dilatation catheter to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Returned device analysis revealed that there was a white foreign material on the skive/bayonet of the device. Follow-up was performed regarding the white foreign material; however, the hospital stated the foreign material was not noticed.

 
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Brand NameRX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula , CA 92591-4628
9519143996
MDR Report Key8011672
Report Number2024168-2018-08224
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue Number1008197-20
Device LOT Number6071961
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/03/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2016
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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