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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 1012449-20
Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problem Intimal Dissection (1333)
Event Date 10/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported deflation and inflation issue; however the difficulty to remove appears to be related to circumstances of the procedure. The reported patient effect is a known inherent risk of the procedure and the treatment appears to be related to circumstances of the procedure. 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.
 
Event Description
It was reported that during the procedure to treat a mildly calcified, de novo lesion in the non-tortuous mid obtuse marginal (om) artery, after successful deployment of an unspecified xience stent, a 3. 0x20 nc trek rx balloon dilatation catheter (bdc) was un-packaged and prepped without difficulty. The nc trek rx bdc was then advanced without resistance to the stent to perform routine post-dilatation. When attempting to inflate the nc trek rx using an unspecified inflation device, the balloon did not inflate at all. The inflation device was disconnected, then reconnected to the nc trek rx hub. The balloon was then able to be fully inflated, completing post-dilatation. However, when attempting to deflate the balloon, it would not completely deflate (very slight partial deflation occurred). While the inflated bdc was able to be withdrawn from the stent without causing damage, it was difficult to remove from the circumflex (cx) artery and a dissection resulted from removal difficulty. The bdc balloon was able to be pulled back and wedged into the guide catheter (gc) with both the bdc and gc removed from the anatomy as a single unit. The dissection in the cx was successfully treated with an unspecified stent. There were no adverse patient sequelae and no occurrence of a clinically significant delay. 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 Key6076802
MDR Text Key59081020
Report Number2024168-2016-07555
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 03/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1012449-20
Device Lot Number60824G1
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

Patient Treatment Data
Date Received: 11/03/2016 Patient Sequence Number: 1
Treatment
STENT: XIENCE
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