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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 1012449-20
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2016
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.
 
Event Description
It was reported that the procedure was to treat a lesion in an unspecified artery. An nc trek balloon dilatation catheter (bdc) was selected for the procedure. While inserting the bdc into the rotating hemostatic valve, a little catch was felt resulting in a mild bend in the shaft (hypotube). Resistance was felt during advancement of the bdc through the guiding catheter, it was not moving forward properly and did not exit the guiding catheter. When the bdc was removed from the guiding catheter, only the proximal portion came out and the distal portion remained within the guiding catheter. The guide wire and guiding catheter were removed from the anatomy as a single unit and the distal portion of the bdc was retrieved from the guiding catheter. Another bdc was used to successfully complete the procedure. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported separation and kink were confirmed. The reported difficulty to position with the guiding catheter and rhv could not be replicated in a testing environment due to the condition of the returned device. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. 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 Key6094781
MDR Text Key59877764
Report Number2024168-2016-07868
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
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 02/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number1012449-20
Device Lot Number60721G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated by Manufacturer? Yes
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

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