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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 1012450-12
Device Problems Partial Blockage (1065); Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that a 3. 25x12 nc trek rx balloon dilatation catheter (bdc) was unpackaged without issue. The bdc was then prepped with 50/50 contrast without issue. The bdc was then advanced without issue to a non-calcified lesion in the mid right coronary artery (rca) that was occluded with thrombus on presentation. An attempt was then made to inflate the balloon, however, the lumen felt as if it may be blocked and the balloon only partially inflated. The balloon was completely deflated without issue then re-inflated once to 12 atmospheres without issue, completing dilatation. An attempt was then made to deflate the balloon but it would only partially deflate and was consequently difficult to remove from the vessel. The inflation device was switched out for a syringe and negative pressure was drawn for 45 seconds, but the balloon would still not completely deflate. The contrast media was then changed out for straight saline and the balloon was able to be further deflated enough to withdraw the device from the anatomy, but the balloon was ultimately not completely deflated. There were no adverse patient sequelae and no occurrence of a clinically significant delay. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device returned for analysis. The complaint investigation determined the reported difficulty was confirmed and the issue was determined to be 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. (b)(4).
 
Event Description
Subsequent to the initial filed medwatch report, additional information received indicates that the reported inflation, deflation, and removal difficulty issues with the 3. 25x12 nc trek rx balloon dilatation catheter (bdc) occurred while post-dilating an unspecified stent that had been previously deployed in the right coronary artery, not during dilatation of the vessel itself. This caused prolonged balloon inflation. The balloon would not deflate despite several attempts. It eventually deflated. No additional information was provided.
 
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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 Key6270528
MDR Text Key65513962
Report Number2024168-2017-00619
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 04/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1012450-12
Device Lot Number60831G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/20/2017
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

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