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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 1012452-12
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. On (b)(6) 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 additional relevant information.
 
Event Description
It was reported that the procedure was to treat a de novo lesion in the moderately tortuous, right coronary artery (rca). A 3. 75 x 12 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure. During advancement of the bdc to the lesion resistance was felt with the anatomy and possibly the guiding catheter, the shaft separated mid shaft into two pieces and all pieces were retrieved from the anatomy. An unspecified bdc was used to successfully complete the procedure. There was a 5 to 10 minute delay in the procedure to facilitate the retrieval of the bdc and prep a replacement device. There was no reported adverse patient sequela. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Remedial action initiated changed from recall to other-none. Action reported to fda changed from unk to na. Evaluation summary: visual and dimensional inspections were performed on the returned device. The shaft separation was confirmed. The difficulty positioning the device with the guiding catheter could not be replicated in a testing environment due to the condition of the returned device. The failure to advance could not be replicated in a testing environment as it was based on operational circumstances. 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. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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 Key6455186
MDR Text Key71713380
Report Number2024168-2017-02765
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
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 05/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number1012452-12
Device Lot Number60217G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
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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