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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 1012450-20
Device Problems Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The reported difficulty positioning the guiding catheter, the difficulty removing the device from the guiding catheter, the stretched shaft and bunched balloon were confirmed. The reported difficulty positioning the device with the stent delivery system 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 operational context. There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
 
Event Description
Subsequent to the initial 30-day medwatch report it was noted that the nc trek balloon met resistance as the balloon and the xience alpine stent delivery system (sds) were together inside the guide catheter. Both devices were removed together with the guide catheter from the anatomy. No additional information was provided.
 
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 additional relevant information.
 
Event Description
It was reported that during advancement into the left anterior descending (lad) stented lesion, the nc trek balloon met resistance with the guide catheter and the implanted xience alpine stent. The balloon met unspecified resistance during removal and was removed with the guide catheter. It was noted after removal that the shaft was stretched and the balloon wrinkled. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. 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 Key7252377
MDR Text Key167718255
Report Number2024168-2018-00920
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCO
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 02/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number1012450-20
Device Lot Number70713G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
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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