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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 1012449-15
Device Problems Break (1069); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that while loading the nc trek balloon onto the guide wire the tip of the balloon appeared kinked. The device was not used; there was no patient interaction. A different device was used in the procedure without issue. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided. Return device analysis revealed the inner member was separated at the proximal balloon marker; the outer member was intact.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis and abbott vascular (av) identified that the proximal seal was stretched and the inner member had a separation at the proximal balloon marker. It is likely that the account perceived the stretched proximal seal/inner member separation as the kink. The analysis of the returned device suggests that the separation may be related to tensile overload when removing the protective sheath. A search of the lot history record for this specific lot indicated no related non-conformance records. Further assessment was performed per operating procedures and av concluded that there is no indication of a product quality issue. The performance of these devices will continue to be monitored.
 
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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 Key6153305
MDR Text Key61890590
Report Number2024168-2016-08659
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,Followup
Report Date 04/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number1012449-15
Device Lot Number50812G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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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