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

Model Number 700009XT

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

When deploying the cleaner, the sinusoidal wire bent at the tip.The device was also difficult to remove after issue.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

When deploying the cleaner, the sinusoidal wire bent at the tip.The device was also difficult to remove after issue.

Manufacturer Narrative

A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found that the distal end of the sinusoidal wire was misshapen, meaning instead of going straight after the last wave, it followed the path of the wave.Thus confirming the complaint.The samples are being sent back to the supplier for further investigation.A scar has been issued to notify the supplier roechling medical lancaster that an investigation is necessary.Per the supplier's investigation, they will take necessary corrective measures.

Event Description

When deploying the cleaner, the sinusoidal wire bent at the tip.The device was also difficult to remove after issue.

Event Description

When deploying the cleaner, the sinusoidal wire bent at the tip.The device was also difficult to remove after issue.

Manufacturer Narrative

A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found that the distal end of the sinusoidal wire was misshapen, meaning instead of going straight after the last wave, it followed the path of the wave.Thus confirming the complaint.The samples are being sent back to the supplier for further investigation.A scar# s-2020-00005 has been issued to notify the supplier roechling medical lancaster that an investigation is necessary.Per the supplier's investigation, they will take necessary corrective measures.

• 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: 13251527
• MDR Text Key: 286000557
• Report Number: 0001625425-2022-00926
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

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: REF210029/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 12/28/2021; 12/28/2021
• Supplement Dates FDA Received: 02/07/2022; 02/14/2022
• 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