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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 1012453-12
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
Internal file number -(b)(4). The device was not returned for evaluation. 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. The nc trek rx coronary dilatation catheters, instruction for use states that if resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter. The investigation determined the reported difficulty positioning the device appears to be related to circumstances of the procedure; however, the reported shaft separation appears to be related to user error. There is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
 
Manufacturer Narrative
The patient and device codes were coded by the manufacturer. (b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The other nc trek referenced is filed under a separate medwatch report.
 
Event Description
It was reported that during a left anterior descending coronary artery procedure, two 4. 0 x 12 mm nc trek dilatation catheters were attempted to be used in a kissing balloon technique. Both dilatation catheters were inserted into a 6french guide catheter. As the dilatation catheters were inserted, resistance was noted. It was thought that the guide wires became tangled and the dilatation catheters had resistance advancing over the guide wires. An attempt was made to force the dilatation catheters through the guide catheters, but the shafts separated. Both separated nc trek catheters were easily removed. There was no adverse patient effect or a clinically significant delay. No additional information was provided.
 
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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 Key7180871
MDR Text Key264245810
Report Number2024168-2018-00273
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 01/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number1012453-12
Device Lot Number70822G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2017
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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