MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 65CM

Model Number 700009XT

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

Argon cleaner device and found there was an issue with it not working properly so they had to open an additional one.They kept the product in the box.Dr.(b)(6) had inserted the device it was working and spinning properly but when he started to pull the device out, the entire wire was coming out as well.So they stopped to try and fix it but it would no longer stay in the device and was no longer spinning.At this point they put it aside and opened a new one to continue the procedure.

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot number was conducted.There were no deviations or non-conformances recorded.A review of returned product from the customer was performed.Visual inspection of the sample found the catheter and guidewire were kinked/damaged.Dried blood/ body fluids were also found on the device.The device for each complaint was functionally tested by turning the power on.It was observed that the control wire rotated but the guidewire did not rotate.The devices were disassembled, and the catheter was removed.The guidewire was found broken on each device approximately 2.3cm (23mm) from the (assembled) ultrasonic weld, with the control wire which was also the same spot where the wire was kinked/damaged.Therefore, these complaints were confirmed.The most probable root cause of this issue could be products getting damaged during shipping or storage, mishandling after reaching the customer facility or prior to use device.Users are to inspect the product/device prior to use for product/device damage and not use device if any damage gets detected.Other possible cause of this issue could be catheter wire getting stuck during procedure and an excessive force applied resulting in the breakage.No corrective action is required at this time because a manufacturing defect could not be confirmed.

Event Description

Argon cleaner device and found there was an issue with it not working properly so they had to open an additional one.They kept the product in the box.(b)(6) had inserted the device it was working and spinning properly but when he started to pull the device out, the entire wire was coming out as well.So they stopped to try and fix it but it would no longer stay in the device and was no longer spinning.At this point they put it aside and opened a new one to continue the procedure.

Manufacturer Narrative

The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.

Event Description

Argon cleaner device and found there was an issue with it not working properly so they had to open an additional one.They kept the product in the box.Dr.Lee had inserted the device it was working and spinning properly but when he started to pull the device out, the entire wire was coming out as well.So they stopped to try and fix it but it would no longer stay in the device and was no longer spinning.At this point they put it aside and opened a new one to continue the procedure.

• Brand Name: CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 65CM
• Type of Device: CLEANER XT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15122938
• MDR Text Key: 296968858
• Report Number: 0001625425-2022-01045
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00886333222308
• UDI-Public: 00886333222308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 700009XT
• Device Catalogue Number: 700009XT
• Device Lot Number: 210042/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 07/15/2022; 07/15/2022
• Supplement Dates FDA Received: 08/29/2022; 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other