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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 1012450-15
Device Problems Detachment Of Device Component (1104); Nonstandard Device (1420); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. 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 #2024168-3/14/2017-002-r.
 
Event Description
It was reported that the nc trek 3. 25 x 15 mm hypotube was separated into two parts when it was inserted into the anatomy. Reportedly, resistance was felt upon advancement of the device. The device was removed without intervention. Another nc trek was used to complete the procedure. There was no reported adverse patient effect and no clincally significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported proximal shaft/hypotube separation was confirmed. The reported difficult to position with the guiding catheter could not be tested due to the condition of the returned device. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the proximal shaft/hypotube separation or difficulty positioning the guiding catheter. Additionally, a review of the complaint history identified no other similar incidents from this lot related to proximal shaft/hypotube separation or difficulty positioning the guiding catheter. The investigation determined the reported proximal shaft/hypotube separation appears to be related to circumstances of the procedure; however, a conclusive cause for the reported difficulty positioning the guiding catheter could not be determined. 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 Key6450156
MDR Text Key71622164
Report Number2024168-2017-02709
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeTW
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 Other
Type of Report Initial,Followup
Report Date 05/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1012450-15
Device Lot Number60810G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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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