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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 1012448-08
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: the device was returned. Visual and dimensional inspections were performed on the returned device. The shaft separation was confirmed. The difficulty positioning and removing of the device 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 similar 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.
 
Event Description
It was reported that the procedure was to treat a lesion in the heavily calcified, heavily tortuous, proximal circumflex coronary artery. A non-abbott stent was implanted. When advancing a 2. 75x08mm nc tek balloon dilatation catheter (bdc), for post dilatation; resistance was felt with the guiding catheter. When removing the bdc from the guiding catheter resistance was felt with the guide catheter and the distal shaft separated in the guide catheter. The distal shaft was removed from the guide catheter by hand and another nc trek bdc was used to complete the procedure. There were no adverse patient effects and no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was sent to the scanning electron microscopy (sem) lab for further analysis. The sem report determined the core failure may be attributed to ductile overload at a bend. The fracture surface revealed dimples, small pits and smearing. The outer and inner surfaces were documented as requested. Surface cracks were observed. There was no damage noted to the bdc prior to use or during preparation, which suggests a product quality issue did not contribute to the reported difficulties. 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 Key7297373
MDR Text Key101132501
Report Number2024168-2018-01386
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151804
UDI-Public08717648151804
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,Followup
Report Date 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number1012448-08
Device Lot Number50904G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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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