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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER

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ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012453-20
Device Problems Deflation Problem (1149); Material Rupture (1546)
Patient Problems Death (1802); Occlusion (1984); Perforation (2001)
Event Date 01/23/2020
Event Type  Death  
Manufacturer Narrative
The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter. The field safety action number is 2024168-1/27/2020-001. This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter. Product from identified lots may exhibit slow, partial or failure to deflate.
 
Event Description
It was reported that on (b)(6) 2020, the patient presented with an st elevated myocardial infarction. A percutaneous coronary intervention was initiated on the left anterior descending (lad), moderately calcified lesion. An nc trek (1012453-20, 90923g1) dilatation catheter advanced to the lesion site and inflated without reported issues. Deflation was attempted; however, the balloon was unable to deflate. As troubleshooting, the balloon was re-inflated. The balloon had then ruptured and the lad perforated. A covered stent was implanted as treatment. The diagonal coronary artery then ¿shut down¿. Pericardiocentesis was performed. On (b)(6) 2020, the patient had expired while in critical care. No additional information as provided regarding this issue.
 
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Brand NameNC TREK RX
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9727825
MDR Text Key180004055
Report Number2024168-2020-01609
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012453-20
Device Catalogue Number1012453-20
Device Lot Number90923G1
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 Received04/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Removal/Correction NumberZ-1133-2020

Patient Treatment Data
Date Received: 02/19/2020 Patient Sequence Number: 1
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