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

Catalog Number 700015

Device Problems Detachment Of Device Component (1104); Retraction Problem (1536)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

There were no samples or images available for review, however, a lot number was provided.A review of the device history records and inspection records was conducted.The review of the lot record documentation indicated that the product was manufactured according to the established processes and procedures.There were no related non-conformances or deviations noted on the specified lots, and the associated operators were trained to the most recent document revisions based on the date of manufacture.It was observed that all released product was tested and identified to be within the ranges specified on the part graphic.Without the sample to review, a definite root cause and corrective action cannot be established.

Event Description

Device perforated and atraumatic tip disengaged when device was retracted, and remained in soft tissue.A stent graft was placed, with good result.Tip was not retrieved; it is ¿jailed¿ behind the stent graft.

• 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: 7310285
• MDR Text Key: 101614337
• Report Number: 1625425-2018-00019
• Device Sequence Number: 1
• Product Code: KRA
• 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: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/07/2020
• Device Catalogue Number: 700015
• Device Lot Number: REF170030/1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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): Required Intervention