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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012451-20
Device Problems Break (1069); Material Split, Cut or Torn (4008)
Patient Problems Air Embolism (1697); Angina (1710); Cardiac Arrest (1762)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
It is unknown if the device is returning for analysis. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported the procedure was to treat a lesion in the left anterior descending (lad) artery. Two stents were implanted and a 3. 50 x 20mm nc trek balloon dilatation catheter (bdc) was used for post dilatation when an air embolism was noted. The patient went into pulseless electrical activity (pea) arrest. Cardiopulmonary resuscitation (cpr) and advanced cardiac life support (acls) were performed. The patient regained consciousness and was transferred to the intensive care unit (icu). After the procedure, the bdc was inspected and the shaft was noted to be fractured (not separated) and torn. The patient was discharged two days later. No additional information was provided.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
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 Key10876526
MDR Text Key217425035
Report Number2024168-2020-09778
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
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number1012451-20
Device Catalogue Number1012451-20
Device Lot Number81016G1
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 Received12/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2018
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: 11/20/2020 Patient Sequence Number: 1
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