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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012274-15
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult to Remove (1528)
Patient Problem No Patient Involvement (2645)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Visual and functional inspection was performed on the returned device. The reported shaft separation was confirmed. The reported difficulty removing the device could not be confirmed. The reported kink was not confirmed; however, it is likely that the reported kink was located at the separated location noted during return analysis. 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. The investigation was unable to determine a conclusive cause for the reported kink and difficulty removing the device from the hoop/tray; however, the reported separation appears to be related to circumstances of the procedure. 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 when the 3. 0 x 15 mm trek dilatation catheter was being removed from the dispenser hoop, some resistance was noted. It was thought that the trek catheter shaft was likely bent. The shaft separated into two segments and the device was not used. There was no patient involvement and no clinically significant delay. No additional information was provided.
 
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Brand NameTREK 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 Key7220494
MDR Text Key98458028
Report Number2024168-2018-00618
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138430
UDI-Public08717648138430
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
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 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number1012274-15
Device Lot Number71109G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
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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