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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 1012447-12
Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(6). Visual inspection was performed on the returned device. The reported balloon separation was not confirmed; the noted hypotube separation is likely what the account perceived as the separation. The reported device operated differently could not be replicated in a testing environment as it was 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 identified no other incidents reported 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.
 
Event Description
It was reported that this was a percutaneous intervention, treating a bifurcation lesion in the left anterior descending and diagonal coronary arteries. A 2. 5x12mm nc trek dilatation catheter was advanced inside the guide catheter, without resistance; the device felt different during this advancement. It was confirmed there was no resistance met, however, while in the guide catheter, the balloon separated into two pieces. The nc trek catheter and unspecified guidewire were removed as a single unit. There was no clinically significant delay and there were no adverse patient effects. There was no additional information provided regarding this issue.
 
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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 Key7271218
MDR Text Key100149421
Report Number2024168-2018-01102
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
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
Report Date 02/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number1012447-12
Device Lot Number71028G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
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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