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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 1012452-08
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/29/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer reported the device is retained by the hospital and not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a de novo lesion in the non-tortuous, moderately calcified, 90% stenosed proximal left anterior descending (lad) coronary artery. A 3. 75 x 8 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure utilizing the kissing balloon method. There was no resistance felt while removing the protective mandrel/sheath removal, there were no issues noted during prep (air aspiration), but the balloon was not soaked in saline prior to use. The bdc was advanced with no resistance to the lesion and inflated to 12 atmospheres with no issues noted; however the balloon would not fully deflate even after several attempts. The balloon was re-inflated to 14 atmospheres, but would still only partially deflate. The guiding catheter and bdc were removed from the anatomy as a single unit. Upon removal for the anatomy the bdc was inspected and no tear, kink, or shaft separation were found. Another attempt was made to fully deflate the balloon which was unsuccessful. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. No additional information was provided.
 
Manufacturer Narrative
(b)(4). It was initially reported that the device would not be returning for analysis; however, the device was returned. 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 (b)(6) 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 (b)(6) 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 (b)(4).
 
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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 Key6191944
MDR Text Key63215884
Report Number2024168-2016-09078
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBE
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,Followup
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1012452-08
Device Lot Number60810G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2016
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 Manufactured08/01/2016
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: 12/20/2016 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: JL4
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