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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 1012450-20
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2017
Event Type  Injury  
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, [medwatch # 2024168-2017-02310]. 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 3. 25 x 20 mm nc trek dilatation catheter was advanced, over an unspecified guide wire, into the patient anatomy to perform post-dilatation of an unspecified stent. The guide wire was not wiped prior to advancement of the nc trek, and there was some resistance between the two devices during advancement; however, the nc trek was able to advance to the target lesion. An attempt was made to reposition the balloon within the stent; however, it was noted that the device shaft broke in the mid-section of the device, while in the guide catheter. A 3. 0 non-abbott dilatation catheter was advanced into the guide catheter and inflated in order to trap the separated device. All devices were then removed as a single unit, including all segments of the separated device. The procedure continued with use of a non-abbott dilatation catheter. There was no adverse patient effect. A delay in procedure was reported, due to the device separation; however, it was not clinically significant. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The shaft separation was confirmed. The difficulty positioning the guide wire was not confirmed. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
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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 Key6488961
MDR Text Key72655947
Report Number2024168-2017-03116
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 05/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number1012450-20
Device Lot Number60929G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2017 Patient Sequence Number: 1
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