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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 1012455-15
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2020
Event Type  Injury  
Manufacturer Narrative
The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat an st elevation myocardial infarction (stemi) patient. Two stents were placed in the vein graft. The 5. 0x15 mm nc trek balloon dilatation catheter (bdc) was used for post dilatation. Multiple inflations were performed. The balloon did not deflate, the bdc would not pull back into the guide catheter. Different attempts were made to remove the bdc; however, in the end the balloon snapped off inside the guide catheter. The devices were removed as a single unit. After all this, the implanted stents were observed to be damaged. Two additional stents were implanted, covering the damaged stents. The patient was stable and the procedure was finished safely. 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 Key9950536
MDR Text Key187304246
Report Number2024168-2020-03577
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648152153
UDI-Public08717648152153
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 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012455-15
Device Catalogue Number1012455-15
Device Lot Number00206G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2020
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: 04/10/2020 Patient Sequence Number: 1
Treatment
GUIDE WIRE
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