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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 1012452-15
Device Problems Difficult To Position (1467); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2018
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 was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was a percutaneous coronary intervention performed with a 3. 75 x 15 mm nc trek dilatation catheter. The nc trek was unable to be advanced over a balance middle weight (bmw) guide wire. The guide wire would not exit the guide wire exit notch. The nc trek was not introduced in the patient. A new nc trek was successfully used with the same bmw guide wire. There was no patient involvement and no clinically significant delay in the procedure. No additional information was provided. Return device analysis found a stretched segment on the shaft of the nc trek.
 
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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 Key7592495
MDR Text Key111052129
Report Number2024168-2018-04404
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number1012452-15
Device Lot Number80217G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
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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