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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 09/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the non-tortuous, moderately calcified, 85% stenosed distal left anterior descending coronary artery. A 3. 00 x 15 mm nc trek balloon dilatation catheter (bdc) was selected for the procedure. The bdc was advanced with resistance toward the lesion and before reaching the lesion the proximal shaft of the bdc was observed to be kinked. The bdc was removed from the anatomy and another 3. 00 x 15 mm nc trek bdc was used to successfully complete the procedure. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. Returned device analysis revealed a proximal shaft separation which has been confirmed to have occurred during use in the patient. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported separation was confirmed. The reported kink was not confirmed; however, it is likely that the kink reported was located at the separated location. The reported failure to advance could not be replicated in a testing environment as it is based on operational circumstances. In this case, it is possible that the balloon dilatation catheter (bdc) interacted with the moderately calcified and 85% stenosed lesion resulting in the failure to cross. Further handling of the bdc during the attempt to cross the lesion likely caused the shaft to kink and subsequently separate. 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 incidents from this lot. The investigation determined the reported difficulties appear 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.
 
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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 Key6212811
MDR Text Key63807024
Report Number2024168-2016-09324
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 01/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue Number1012449-15
Device Lot Number60407G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
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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