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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 1012448-12
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 procedure was to treat a lesion located in the distal obtuse marginal (om3) artery with no tortuosity and no calcification. Resistance was not felt during advancement of the 2. 75mm x 12 mm nc trek rx balloon dilatation catheter (bdc) through the lesion and it crossed successfully for post-dilatation. The balloon failed to inflate and no contrast was observed in the balloon. A non-abbott replacement bdc was used to complete the procedure. There were no adverse patient effects or clinically significant delay in the procedure reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). 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.
 
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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 Key6194036
MDR Text Key63316271
Report Number2024168-2016-09100
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 Recall
Type of Report Initial,Followup
Report Date 03/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1012448-12
Device Lot Number60804G1
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
Date Device Manufactured08/01/2016
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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