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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 1012445-12
Device Problems Inflation Problem (1310); Difficult to Remove (1528); Material Separation (1562); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical produts: vessel closure: 3 proglides. 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 the procedure was to treat a moderately tortuous circumflex and left anterior descending artery during a kissing balloon technique. A 2. 0 x 12 mm nc trek balloon catheter was used and did not meet any resistance during advancement. However, the balloon completely failed to inflate and a hissing noise was reported. Additionally, the device met resistance during removal with the anatomy, and the shaft near the hub separated. Therefore, the device was removed independently and another 2. 0 x 12 mm nc trek balloon catheter was used without issues. However, the patient expired 50 minutes post procedure. It was reported that the nc trek balloon catheter did not cause or contribute to the death. It was reported that the death was due to a retroperitoneal bleed caused by the 14fr sheath and dilator. There were no adverse patient effects and no 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 Key8514482
MDR Text Key141946463
Report Number2024168-2019-02910
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 Modification/Adjustment
Type of Report Initial,Followup
Report Date 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number1012445-12
Device Lot Number70706G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
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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