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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 Kinked (1339); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4). Device code 2017: above rated burst pressure evaluation summary: visual and functional inspections were performed on the returned device. The reported kink and leak were confirmed. 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. It should be noted coronary dilatation catheters, nc trek rx, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp). In this case, it is unlikely the ifu violation contributed to the reported event. The investigation determined the reported issues appear to be related to operational context as the device was likely damaged during advancement resulting in the reported kink and inflation issue. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
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 relevant information.
 
Event Description
It was reported the procedure was performed to treat a lesion located in the proximal left anterior descending artery. Dilatation was to be performed with the 2. 75 x 8 mm nc trek. There was no resistance felt during advancement of the balloon catheter to the lesion. When an attempt was made to inflate the balloon to 20 atmospheres, it was found that the shaft was bent/kinked and had a hole visible evidenced by a leak. Another nc trek of the same size was used to successfully complete the procedure. No adverse patient effects or clinically significant delay in the procedure were reported. 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 Key7217238
MDR Text Key194233240
Report Number2024168-2018-00573
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 03/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number1012448-08
Device Lot Number70412G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
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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