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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 1012451-20
Device Problems Break (1069); Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 08/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual inspection was performed on the returned device. The reported kink was not confirmed; however, the shaft was stretched at the proximal seal and the inner member was separated at the proximal marker which was likely what the account perceived as the kink on the distal shaft. The investigation was unable to determine a conclusive cause for the reported kink and the noted stretched shaft at the proximal seal and the inner member separation at the proximal marker. 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. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that a kink was noticed on the distal part of the shaft on a 3. 50x20mm nc trek prior to use. The device was not used. The procedure was successfully completed with another unknown device. Return device analysis revealed a separation of the innermember. Follow-up information stated that there was no reported resistance during removal of the protective sheath. No additionally information was provided.
 
Manufacturer Narrative
(b)(4). 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 # 2024168-2017-02310]. Corrective action has been implemented per site operating procedures. The product will continue to be trended. The abbott internal recall number is 2024168-3/14/2017-002-r.
 
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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 Key6052081
MDR Text Key58322854
Report Number2024168-2016-07242
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
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 04/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number1012451-20
Device Lot Number60603G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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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