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

Catalog Number 700009XT

Device Problems Break (1069); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going, and a follow-up report will be submitted once the evaluation is complete.

Event Description

Doctor made 2-3 previous successful passes and on the 4th pass the wire snapped off when it was fully extended where the sheath and the wire meet.Doctor used a loop snare to grab the loose piece with no issue.Doctor opened another device with zero issues.

Manufacturer Narrative

A review of returned product from the customer was performed.Visual inspection showed that catheter wire was broken from the control or rotator wire.This device is assembled by a supplier, so the supplier was asked to investigate the issue.A summary of the supplier's investigation is below: a device history record review was performed.The review indicated that the product was manufactured according to the established processes and procedures.There were no related non-conformances or deviations noted, and the associated operators were trained on the most recent document revisions.Review of the actual sample showed that the guidewire was fractured approximately 3" from the distal tip.The guidewire was also kinked significantly approximately 1/2" behind the tip.The root cause is unknown.It is possible that the catheter was stuck during the procedure while the motor was turned on preventing the wire from spinning.

• 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
• MDR Report Key: 7814678
• MDR Text Key: 118402325
• Report Number: 1625425-2018-00132
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• PMA/PMN Number: K120346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2021
• Device Catalogue Number: 700009XT
• Device Lot Number: REF180022/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• 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): Required Intervention