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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 1012268-12U
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 08/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual and functional inspections were performed on the returned device. The reported crack 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. The investigation determined the reported crack and leak appear to be related to operation context. 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 during device preparation and prior to use in the anatomy, the trek leaked at the hub area due to a crack in the luer. There was no patient involvement; the device was not used. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMINI TREK CORONARY DILATATION CATHETER
Type of DeviceBALLOON 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 Key6850590
MDR Text Key85298400
Report Number2024168-2017-07346
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110617
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 09/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Catalogue Number1012268-12U
Device Lot Number70605G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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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