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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 1008201-20
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was initially reported as returning for analysis, but has now been reported as not returning because it was discarded at the account. The device was not returned for analysis. It is likely that during use the clearance between the guide wire lumen and the guide wire became reduced causing resistance. Further attempts to move the balloon dilatation catheter (bdc) from the guide wire likely caused the devices to become frozen together resulting in the separation. A review of the lot history records revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other incidents. The investigation determined the reported difficulties were likely due to case circumstances. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device was discarded. Investigation is not yet complete. A follow-up will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat a de novo lesion in the non-tortuous, heavily calcified, 80% stenosed, mid right subclavian artery. A 7. 0 x 20 mm viatrac plus balloon dilatation catheter (bdc) was selected for the procedure. Following inflation of the balloon, significant resistance was felt while trying to retract the bdc over the unspecified guide wire. This resulted in the balloon separating from the shaft of the bdc and being stuck on the guide wire. The guide wire and balloon were successfully removed together from the anatomy without incident. An unspecified guide wire was reinserted into the anatomy across the lesion and the procedure was completed with the successful deployment of an unspecified stent implant. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. No additional information provided.
 
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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 Key7101997
MDR Text Key248580106
Report Number2024168-2017-09538
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number1008201-20
Device Lot Number7071361
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 Received01/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2017
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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