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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 1012447-15
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Visual, dimensional and functional inspections were performed on the returned device. The reported separation was confirmed. The reported difficulty to position the device over the guide wire was not 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 similar incidents from this lot. The investigation determined the reported shaft separation appears to be related to circumstances of the procedure; however, a conclusive cause for the reported difficulty positioning the guiding catheter could not be determined. 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 an unknown lesion. A 2. 5 x 15 mm nc trek balloon dilatation catheter was being advanced over an unknown guide wire; however, prior to entering the patient anatomy, resistance was felt with the guide wire and it was then noticed that the hypotube had separated in the guiding catheter. The separated portion was removed without issue and without requiring intervention. The procedure was successfully completed with another nc trek device. There was no reported resistance during removal of the protective sheath and the device was prepped according to the instructions for use. There was no clinically significant delay in the 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 Key6995049
MDR Text Key91328033
Report Number2024168-2017-08598
Device Sequence Number1
Product Code LOX
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
Report Date 11/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number1012447-15
Device Lot Number70210G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2017
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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