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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 1012452-15
Device Problems Difficult To Position (1467); Difficult to Remove (1528); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was returned for analysis. Visual, dimensional and functional testing was performed on the returned device. The reported difficulty removing the protective sheath could not be tested due the sheath not being returned. The reported difficulty advancing over the guide wire and missing balloon marker was not confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history did not indicate a lot specific quality issue. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath. The reported resistance with the guide wire appears to be related to the circumstances of the procedure. The reported missing marker likely appeared missing due to the stretched inner member.
 
Event Description
It was reported the protective sheath was difficult to remove from the 3. 75x15 mm nc trek rx balloon dilatation catheter (bdc). The protective sheath came off after it was put under water. The balloon was prepped through the distal tip with a squirt of saline. The nc trek bdc could not advance smoothly over the guide wire; the guide wire could not advance past the balloon wrapping. The nc trek bdc was removed. Another attempt was made and with difficulty the bdc was able to be loaded onto the guide wire. The bdc was removed. It was noted that the nc trek did not have a proximal marker; there was only a distal balloon marker. A new nc trek bdc was successfully used to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). 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 Key5579188
MDR Text Key43179509
Report Number2024168-2016-02432
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 03/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number1012452-15
Device Lot Number50420G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/30/2016
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 Manufactured04/01/2015
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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