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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR NC TREK RX & VOYAGER NC CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012454-15
Device Problem Deflation Problem (1149)
Patient Problems Angina (1710); Occlusion (1984)
Event Date 05/05/2020
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. 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 to treat a moderately tortuous, mildly calcified de novo right coronary artery that was 80% stenosed. A 4. 5x15mm nc trek balloon reached the lesion and was inflated once at 18 atmospheres but failed to deflate after post-dilatation. Patient experienced chest pain due to no flow noted. The balloon was able to be intentionally burst and the entire system was removed. It is not known how the physician burst the balloon. No new device was used to further treat the patient. There was no adverse patient sequela or clinically significant delay reported. No additional information was provided.
 
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Brand NameNC TREK RX & VOYAGER NC
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 Key10078505
MDR Text Key191676154
Report Number2024168-2020-04448
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152115
UDI-Public08717648152115
Combination Product (y/n)N
Reporter Country CodeMY
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 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
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 Number00116G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2020
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: 05/21/2020 Patient Sequence Number: 1
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