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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 1012454-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed on (b)(6) 2021 to treat a lesion in the right coronary artery. A 4. 0 mm xience stent was implanted. Post-dilatation was being performed as standard procedure with a 4. 50 x 15 mm nc trek rx balloon dilatation catheter (bdc) and the balloon was inflated four times up to 22 atmospheres; however, the balloon was slow to deflate. However, in this case although the pressure dropped in the indeflator, the balloon did not deflate immediately. Contrast did clear after a combination of suction with luer lock syringe and traction to try and pull the balloon back to the guide catheter. The physician suspected the balloon had burst because the pressure dropped in the indeflator. The bdc was attempted to be removed but resistance was felt with the implanted stent and the guiding catheter and the balloon detached from the shaft. The patient was transferred to another facility and an unspecified drug eluting stent (des) was implanted and successfully apposed the balloon to the vessel wall. The patient had an uncomplicated discharge on (b)(6) 2021. 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 Key11304505
MDR Text Key231174190
Report Number2024168-2021-01028
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152115
UDI-Public08717648152115
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012454-15
Device Catalogue Number1012454-15
Device Lot Number00615G1
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 Received04/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2020
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: 02/09/2021 Patient Sequence Number: 1
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