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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 1012453-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Stretched (1601); Mushroomed (2987)
Patient Problem Ischemia (1942)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The rx trek device referenced is being filed under a separate medwatch report. Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported deflation difficulty was unable to be confirmed. The reported separation and stretching was confirmed. The reported material twist (accordion) could not be confirmed; however, it is likely that the account perceived the noted balloon folded towards itself at the distal end as the reported material twisted (accordion). The reported difficulty removing the device from the anatomy could not be replicated in a testing environment as it was based on operational circumstances. 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 issue since the complaint could not be confirmed during return analysis. The investigation determined the reported difficulty removing the device from the anatomy, the stretching, material twist and patient effect of ischemia appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported the procedure was to treat a heavily calcified lesion in the ostium of the left anterior descending (lad) artery. Atherectomy was performed to prep the lesion. The 3. 0x20mm rx trek balloon catheter was advanced and the balloon was inflated however would not deflate. Negative was pulled for 3-4 minutes with a syringe and the balloon deflated enough to be removed from the patient with no resistance. A stent was placed in the left main (lm) and post dilated with a 4. 0x15mm nc trek balloon catheter. The balloon was inflated to 10atm however failed to deflate and the patient became symptomatic (ischemic). The inflated balloon was removed to the guide with resistance noted with the anatomy. Everything was removed as a whole system. The procedure was completed with another nc trek balloon. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided. Post procedure, the abbott vascular sales rep looked at the nc trek device and noted the shaft was stretched proximal to the proximal balloon seal and the shaft was accordion looking. Also, he reviewed the cines and noted the physician did not wait until the balloon was deflated prior to removal.
 
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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 Key7623483
MDR Text Key112001667
Report Number2024168-2018-04741
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number1012453-15
Device Lot Number80419G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2018
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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