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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
Device Problems Inflation Problem (1310); Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event - estimate. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the nc trek balloons have a slow inflation time, poor re-wrap, difficulty to remove the protective sheath, and stretched distal shaft. Additionally, it was reported that the profile on some balloons is high causing difficulty during removal through a 6 fr guiding catheter. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The udi# is unknown because the part number and lot number were not provided. The device was not returned for analysis. The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath. On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues. Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints. To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on march 17, 2017 [medwatch # 2024168-2017-02310]. Corrective action has been implemented per site operating procedures. The product will continue to be trended. The abbott internal recall number is 2024168-3/14/2017-002-r.
 
Event Description
Additional information: it was reported that when using two balloons in a kissing balloon technique the profile on some balloons is high causing difficulty during advancement and removal through a 6 fr guiding catheter. 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 Key6187426
MDR Text Key63192872
Report Number2024168-2016-09019
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received03/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2016 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: 6F
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