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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 1012452-15
Device Problems Deflation Problem (1149); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Correction: the date received by manufacturer date was filed incorrectly on the initial medwatch report as 12/18/2017, but should have been 11/12/2017.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for analysis. The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath. On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues. Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints. To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on march 17, 2017 [medwatch#2024868-2017-02310]. Corrective action has been implemented per site operating procedures. This product will continue to be trended. The abbott internal recall number is 2024168-3/14/2017-002r.
 
Event Description
It was reported that during a coronary artery procedure, the 3. 75 x 15 mm nc trek balloon dilatation catheter (bdc) was inflated at high pressure, but failed to deflate. Attempts were made to deflate the balloon, but it would not deflate, so the device was slowly removed and the proximal shaft kinked. There was no reported adverse patient sequela or a clinically significant delay in 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 Key7197846
MDR Text Key133372294
Report Number2024168-2018-00422
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152030
UDI-Public08717648152030
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number1012452-15
Device Lot Number60718G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2037-2039-2017

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