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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 1012449-08
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Actual weight (b)(6). (b)(4). The device was returned for evaluation. The whisper guide wire used in the procedure was not returned. A proxy whisper ms wire was advanced through the guide wire lumen without any resistance noted; thus, the reported difficulty was not confirmed. Based on 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 was unable to determine a conclusive cause for the reported difficulties. 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 identified no other incidents reported from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that during a procedure of the left anterior descending (lad) artery, the nc trek was attempted for post-dilatation but the balloon met resistance during advancing over the whisper ms guide wire. The devices were removed from the anatomy together as a single unit. The whisper ms guide wire was used again in the procedure with a different nc trek balloon without issue. There was no reported adverse patient effect. There was no reported 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)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key5408778
MDR Text Key37733799
Report Number2024168-2016-00621
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
Report Date 02/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number1012449-08
Device Lot Number5030562
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
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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