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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 1012446-15
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat a 90% stenosed, moderately tortuous, and heavily calcified de novo lesion in the mid left anterior descending artery. Following pre-dilatation with multiple balloons, a 2. 25x15mm nc trek balloon dilatation catheter (bdc) was being reused; however, the bdc became stuck in the guiding catheter during advancement. The proximal shaft kinked and separated. The separated portion was simply withdrawn out of the guiding catheter and the procedure was successfully completed with another unknown device. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
Internal file number - (b)(4). Evaluation summary: visual inspection was performed. The reported shaft separation and kink were confirmed. The reported difficulty positioning the device could not be replicated in a testing environment due to the condition of the returned device. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. 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 as it is likely that the reported difficulty positioning the device contributed to the reported kink and separation. 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 Key7465964
MDR Text Key106723265
Report Number2024168-2018-03101
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBE
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,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue Number1012446-15
Device Lot Number70123G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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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