MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number 700015

Device Problem Component Missing (2306)

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

Event Date 06/14/2017

Event Type  malfunction  

Event Description

When the catheter was removed from the patient, the white tip was missing and appeared in the filter tubing for perfusion.

• Brand Name: CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 6692664
• MDR Text Key: 79269838
• Report Number: 6692664
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 700015
• Device Catalogue Number: 700015
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR