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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 1012446-15
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2020
Event Type  malfunction  
Manufacturer Narrative
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. The 2. 5x15mm nc trek and 2. 5x20mm nc trek referenced are filed under separate medwatch report numbers.
 
Event Description
It was reported that the procedure was performed to treat a 90% stenosed, moderately tortuous, heavily calcified, and chronic totally occluded lesion in the first and second diagonal artery and a 90% stenosed, heavily tortuous, heavily calcified, and chronic totally occluded lesion in the obtuse marginal artery. Following thrombus aspiration, pre-dilatation was performed with a 2. 5x20mm nc trek balloon dilatation catheter (bdc) and a 2. 5x48mm xience stent was deployed without issues. A 2. 5x15mm nc trek bdc was advanced to the second diagonal artery and a 2. 5x20mm nc trek bdc was advanced to the anterior descending artery to perform kissing balloon angioplasty; however, the 2. 5x15mm bdc was inflated to 12 atmospheres (atms) and the balloon ruptured. The bdc was removed and new unspecified device was used successfully. A 2. 25x15mm balloon was advanced to the first diagonal artery, but the balloon ruptured when inflated to 12 atms. The bdc was removed and new unspecified device was used successfully. A 2. 5x20mm nc trek bdc was advanced to the obtuse marginal artery and inflated to 12 atms, but again the balloon ruptured. The bdc was removed and a 3. 0x20 non-abbott balloon was used successfully. The procedure was successfully completed with the deployment of a 3. 0x33mm xience stent and post-dilatation with a non-abbott 3. 5x12 bdc. Final timi iii flow was achieved. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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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 Key11095579
MDR Text Key224804651
Report Number2024168-2020-11008
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCO
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 01/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012446-15
Device Catalogue Number1012446-15
Device Lot Number01008G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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