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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 1012447-08
Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 performed to treat a 99% stenosed and moderately tortuous lesion in the left main artery to the mid left anterior descending artery (lad). Following pre-dilatation, st elevation was noted. Aspiration was performed with a thrombectomy device and medication was administered. The st elevation was still slightly noted. Three xience sierra stents (2. 25x38mm, 3. 0x38mm, and 3. 5x23mm) were deployed in the mid lad to the left main artery from the distal side. Proximal optimization technique was also performed in the mid lad and proximal lad with 3. 25mm non-abbott balloon catheter. For kissing balloon technique of the lad artery and the 1st diagonal artery, a 2. 5x8mm nc trek balloon dilatation catheter (bdc) was chosen. The bdc was prepared; however, the stylet was not removed before prep. Additionally, resistance was noted when removing the stylet from the bdc. An attempt was made to insert the bdc onto a non-abbott guide wire; however, the bdc failed to be inserted onto the guide wire. It was thought that the lumen of the bdc collapsed during removal of the stylet. The bdc was not used and the procedure was successfully completed with a 2. 5x6mm non-abbott balloon catheter. 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 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 Key10623042
MDR Text Key214623853
Report Number2024168-2020-08240
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
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 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012447-08
Device Catalogue Number1012447-08
Device Lot Number90927G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2019
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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