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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 1012454-12
Device Problems Kinked (1339); Peeled/Delaminated (1454); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: guide wire: sion, stent: xience xpedition (4. 0 x 28mm, 4. 0 x 12mm, 4. 0 x 15mm). Evaluation summary: visual analysis was performed on the returned device. The kink was confirmed; however, the failure to advance could not be replicated in a testing environment as it is based on operational circumstances. There was balloon material shredding on the distal half of the balloon likely due to interaction with the previously implanted stent. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot 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 determined the reported difficulties appear to be related to circumstances of the procedure.
 
Event Description
It was reported the procedure was to treat a de novo lesion with moderate tortuosity, mild calcification and 70% stenosis in the mid right coronary artery (rca). Pre-dilatation was performed with a 4. 0 x 20 mm nc trek balloon catheter and a 4. 0 x 28 mm xience xpedition was implanted successfully in the distal rca. A 4. 0 x 15 mm xience xpedition and a 4. 0 x 12 mm xience xpedition were implanted in the mid rca successfully. A 4. 5 x 12 nc trek balloon was advanced to post dilate the overlapping stent section, but the 4. 5 x 12 nc trek could not cross the stent implants. The 4. 5 x 12 mm nc trek was withdrawn from the patients anatomy and it was noted the proximal shaft was bent. A 4. 5 x 15 mm non-abbott balloon crossed the stent to complete post-dilatation successfully. There was no adverse patient effect. There was no clinically significant delay in the procedure. No additional information was provided. The return device analysis of the 4. 5 x 12 mm nc trek revealed there material shredding on the distal half of the balloon.
 
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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 Key5987842
MDR Text Key56112635
Report Number2024168-2016-06525
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 09/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number1012454-12
Device Lot Number50812G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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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