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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012449-15
Device Problems Detachment Of Device Component (1104); Kinked (1339); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that during a procedure of the mildly calcified, mildly tortuous, 70% stenosed, mid left anterior descending (lad), the nc trek balloon was advanced but the proximal shaft kinked and separated into two pieces. The device was removed without issue. A different trek balloon was used in the procedure without reported issue. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported separation and kink were confirmed. The reported failure to advance could not be replicated in a testing environment as it is based on operational circumstances. 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 of the reported lot did not indicate a lot specific quality issue. The investigation determined the reported difficulties appear to be related to circumstances of the procedure and there is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
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 Key6109418
MDR Text Key60628962
Report Number2024168-2016-08035
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue Number1012449-15
Device Lot Number40711G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
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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