MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER; CATHETER, CONTINUOUS FLUSH

Catalog Number 700115

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/19/2018

Event Type  Injury  

Event Description

Argon cleaner is wire fractured during procedure.Foreign body was not able to be snared.

• Brand Name: CLEANER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 2600 dallas pkwy. ; ste 440; frisco TX 75034
• MDR Report Key: 7502428
• MDR Text Key: 108001293
• Report Number: MW5077119
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 700115
• Device Lot Number: REF17005511
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 127