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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 1012451-15
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant products: guide wire: sion. Guide catheter: heartrail 2 jl4 6f. Stent: synergy 3. 5x20. 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 performed to treat an eccentric de novo lesion in the mid left anterior descending coronary artery with no tortuosity, no calcification and 90% stenosed. The 3. 5 x 15 mm nc trek was successfully used for initial post dilatation of a non abbott stent and was then removed, without resistance, to check intravascular ultra sound (ivus). The same 3. 5 x 15 mm nc trek was then attempted to be reinserted to perform additional post dilatation. Resistance was met with the y-connector of the guiding catheter during advancement and the shaft kinked, then completely separated at the mid shaft junction and the distal end of the nc trek remained inside the guiding catheter, outside of the patient anatomy. The device was safely removed and a 3. 5 x 12 mm nc trek was used to successfully complete the procedure. There was no clinically significant delay in the procedure. There was no adverse patient effect. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The reported kink and shaft separation were able to be confirmed. The reported difficulty to be positioned could not be 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 of the reported lot revealed no other incidents reported for this shaft separation, kink and difficult to position. 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.
 
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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 Key5624645
MDR Text Key44343826
Report Number2024168-2016-02785
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number1012451-15
Device Lot Number50918G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2015
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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