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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 1012451-12
Device Problems Difficult To Position (1467); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: the device 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
It was reported that the 3. 5x12 mm nc trek balloon dilatation catheter (bdc) could not be advanced over the balance middleweight (bmw) universal guide wire. Thus, the bdc could not be used. Another bdc was used with the same bmw guide wire to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Returned device analysis revealed the outer member was stretched at the proximal seal.
 
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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 Key6461697
MDR Text Key72174777
Report Number2024168-2017-02828
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151972
UDI-Public(01)08717648151972(17)190831(10)60907G1
Combination Product (y/n)N
Reporter Country CodeNL
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 Recall
Type of Report Initial
Report Date 04/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number1012451-12
Device Lot Number60907G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2016
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? Yes
Date Device Manufactured09/01/2016
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: 04/05/2017 Patient Sequence Number: 1
Treatment
GUIDE WIRE: BMW UNIVERSAL
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