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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 1012455-12
Device Problems Deflation Problem (1149); Failure to Fold (1255)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned as it was reportedly discarded. The investigation determined the reported difficulties appear to be related to user preference during the procedure as the physician commented that the length of time during deflation and balloon refold post deflation. This is a personal preference/opinion of the physician and not a quality issue with respect to manufacture, design or labeling with the product. There is no indication of product deficiency or product quality issue with respect to design, manufacture or labeling.
 
Event Description
It was reported as a general comment that the 3. 5mm, 4. 5mm and 5mm sized nc trek devices take longer to deflate compared to a competitor's device, i. E, the balloon folds back and remains bulky after inflation. The nc trek was noted as not ideal for bifurcation procedures. There were no issues noted during removal of the device. There were no adverse patient effects and no clinically significant delay in the procedure. 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 Key8125370
MDR Text Key129079146
Report Number2024168-2018-09223
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
Report Date 12/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number1012455-12
Device Lot Number80917G1
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 Received11/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2018
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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