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

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.

• Brand Name: NC TREK RX
• Type of Device: CORONARY 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 Key: 9931521
• MDR Text Key: 189471933
• Report Number: 2024168-2020-03439
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• 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 Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• 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 Received: 03/12/2020
• 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