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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 1012453-15
Device Problems Deflation Problem (1149); Kinked (1339); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: visual,dimensional and functional inspections were performed on the returned device. The reported kink was confirmed. The reported deflation issue could not be tested due to the condition of the returned device. The reported difficulty positioning with the guiding catheter could not be replicated in a testing environment as it was based on circumstances of the procedure. 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 are related to circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a de novo proximal left anterior descending artery. A 4. 0 x 15 mm nc trek balloon catheter was used for post-dilatation and was inflated one time to nominal pressure. A non-abbott nc balloon catheter was then used for post-dilatation and the same 4. 0 x 15 mm nc trek was being advanced for additional post-dilatation when there was resistance with the guiding catheter and the hypotube kinked when a small amount of force was applied. The device was removed from the anatomy and it was decided not to use it. A non-abbott balloon catheter was successfully used to complete the procedure. An attempt was made outside the anatomy to inflate and deflate the balloon. The balloon inflated without issue but would not deflate. There was no clinically significant delay in procedure and no adverse patient effects. No additional information was provided.
 
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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 Key6643472
MDR Text Key130233644
Report Number2024168-2017-05083
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSN
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 07/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number1012453-15
Device Lot Number70227G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2017
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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