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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 1012447-12
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 the procedure was to treat a lesion in the left anterior descending artery. The nc trek balloon catheter attempted to advance to the target lesion for pre-dilatation; however, during advancing the nc trek balloon got stuck with the guide wire and during the attempt to remove the balloon catheter, the distal shaft portion separated at the junction. Therefore, the devices were removed as one unit successfully from the patient. A new nc trek balloon catheter was used for pre-dilatation successfully. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis and the reported shaft separation was unable to be confirmed however; the bayonet separation is likely what was perceived by the account as the shaft separation. The complaints difficult to position and difficult to remove could not be replicated in a testing environment as it was based on operational circumstances. Based on the visual, dimensional and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling. 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 did not indicate a lot specific quality issue. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key5354706
MDR Text Key35680478
Report Number2024168-2016-00092
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 01/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number1012447-12
Device Lot Number50903G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2016
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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