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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 1012449-15
Device Problems Inflation Problem (1310); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Material Too Soft/Flexible (4007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2019
Event Type  Injury  
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 the 3. 0x15 mm nc trek rx was advanced very quickly to the coronary artery without incident, to treat a perforation in the coronary artery. Attempts were made to inflate the nc trek, but it would not inflate. The nc trek was retracted and the distal shaft was noted to have separated in the patient. When the nc trek was being adjusted at the vessel, the physician believes, that is when the shaft of the nc trek fractured. Another balloon dilatation catheter (bdc) was inserted and inflated past the separated nc trek. The separated segment of the nc trek was removed by retracting the inflated bdc. The nc trek was thought to be more brittle than normal as it separated too easily without resistance felt during advancement. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information 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 Key8519879
MDR Text Key142119784
Report Number2024168-2019-02981
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 Other
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1012449-15
Device Lot Number90219G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/16/2019 Patient Sequence Number: 1
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