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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 1012449-12
Device Problems Difficult To Position (1467); Material Rupture (1546); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: guide wire: sion guide catheter: hyperion stent: xa2. 5-23. The device was not returned for evaluation. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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 incidents from this lot. 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 that the procedure was to treat two lesions. The first was a concentric de novo lesion located in the mid-right coronary artery (rca) that was moderately tortuous, mildly calcified and 90% stenosed. The second was a concentric de novo lesion located in the distal rca that was moderately tortuous, mildly calcified and 90% stenosed. The nc trek rx 3. 0 x 12 mm balloon dilatation catheter was being used for post-dilatation of a deployed stent and had difficulty crossing the tortuous vessel, and inside the deployed stent, however successfully crossed. When inflated for the first time, the balloon ruptured at 8 atmospheres. The device was removed from the anatomy and was replaced with a non-abbott balloon dilatation catheter to complete the procedure. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. 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 Key6638138
MDR Text Key77527833
Report Number2024168-2017-05032
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
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 06/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number1012449-12
Device Lot Number70315G1
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 Received05/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2017
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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