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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 1012453-15
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu), states: balloon pressure should not exceed the rated burst pressure (rbp). The rbp for the nc trek rx device is 18 atm. In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint. The investigation determined the reported complaints, foreign body in patient, surgical procedure, nonsurgical treatment/delay and additional treatment appear to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a moderately tortuous, moderately calcified, and chronic total occlusion (cto) in the mid left anterior descending artery (lad). An unspecified guide catheter was advanced though the radial access and a 4. 0x15mm nc trek rx balloon dilatation catheter (bdc) was used to post-dilate an unspecified deployed stent to 24 atmospheres. An attempt to remove a non-abbott guide wire and the bdc was made; however, the bdc could not be removed due to resistance with the anatomy and the non-abbott guide wire. An attempt to pull out the bdc with a larger sheath was made, but unsuccessful. The bdc could not be retrieved from the patient from the radial part of the artery directly after finishing the procedure. The patient was discharged for vascular surgery; however, it could not be confirmed if the device was removed. A clinically significant delay was reported. 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 Key9931521
MDR Text Key189471933
Report Number2024168-2020-03439
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012453-15
Device Catalogue Number1012453-15
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 Received03/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/06/2020 Patient Sequence Number: 1
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