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

Model Number 1012450-15

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual and dimensional inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the stylet/mandrel could not be replicated in a testing environment due to the condition of the returned device.It was reported that the device was prepped prior to trying to remove the stylet.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) states: remove the protective mandrel from the flushing sheath.Then continue with following steps to prepare the device.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the stylet/mandrel; however, the reported tip separation appears 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 during preparation of the 3.25x15 nc trek, the balloon was removed from the hoop, but the stylet was noticed to be stuck inside the balloon catheter.Additional force was applied to remove the stylet.It was noted that when removing the stylet, the orange tip at the end of the balloon had been pulled off.The device was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• 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: 11484328
• MDR Text Key: 241929574
• Report Number: 2024168-2021-02021
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151934
• UDI-Public: 08717648151934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 1012450-15
• Device Catalogue Number: 1012450-15
• Device Lot Number: 01105G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1