MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 135CM

Catalog Number 700109XT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

The sample device was returned on 2/26/2020.An evaluation of the device is in progress.A follow-up report will be provided by 3/25/2020.

Event Description

Gt hold 3 24 left brachiocephalic fistula thrombosis.Tpa given to outflow vein and thrombus outflow vein was small in caliber.Opened cleaner device in distal cephalic vein and turned on device.Did not attached to device.Attempted retrieval but vein spasmed and aborted retrieval.Left inappear to spin.Slowly pulled back and tip was no longer patient.

Manufacturer Narrative

A review found the device turns on/off without issue but the sinous tip is missing from the device, confirming the complaint.Scar# (b)(4) has been issued to notify the supplier that an investigation is necessary.Per the supplier roechling medical- lancaster investigation, necessary corrective measures will be taken.Investigation finding and corrective action will be provided once available.

Event Description

Follow up.

Manufacturer Narrative

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• Brand Name: CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 135CM
• Type of Device: CLEANER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 9758392
• MDR Text Key: 184656533
• Report Number: 1625425-2020-00191
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): Y
• PMA/PMN Number: K141617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 700109XT
• Device Lot Number: REF170029/1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other