MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. CLEANER ROTATIONAL THROMBECTOMY SYSTEM

Catalog Number 700009XT

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

The returned device was examined.The wire and polymer tip were examined under magnification and no issues of burrs or other defects were found.The polymer tip was manipulated with no unusual stiffness.The laceration of the vessel may have occurred due to patient physiological factors, or if a defect was present, it may have been removed during a cleaning process of the sample (fibrous material resembling cotton was found on the tip during the sample evaluation).No manufacturing defects were observed.

Event Description

Dvt treatment, using the 65 cm cleaner xt.Cleaner lacerated femoral vein at femoral head.

• Brand Name: CLEANER ROTATIONAL THROMBECTOMY SYSTEM
• Type of Device: ROTATIONAL THROMBECTOMY SYSTEM
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 6962357
• MDR Text Key: 89744613
• Report Number: 1625425-2017-00143
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 700009XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other