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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 1012449-08
Device Problems Detachment Of Device Component (1104); Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 09/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Visual inspection was performed on the returned device. The reported kink was not confirmed; however, a separation was noted during returned device 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 similar incidents from this lot. The investigation determined that the reported kink appears to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
 
Event Description
It was reported that after removing the nc trek dilatation catheter from the protective hoop, a proximal shaft kink was noted. The device was set aside for return. There was no patient involvement. The device returned appearing to be used and with a separated hypotube.
 
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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 Key6274981
MDR Text Key65948825
Report Number2024168-2017-00665
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151859
UDI-Public(01)08717648151859(17)181031(10)51126G1
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 01/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number1012449-08
Device Lot Number51126G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
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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