MAUDE Adverse Event Report: COVIDIEN MAHURKAR, 12FRENCH / 13CM LENGTH; HEMODIALYSIS CATHETER

Lot Number 1602000128

Device Problems Bent (1059); Material Fragmentation (1261); Defective Device (2588)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/15/2016

Event Type  Injury  

Event Description

Covidien's mahurkar elite catheter was placed for temporary dialysis in the right common femoral vein.The procedure was uneventful with removal of a guidewire.On abdominal xr the guide wire was still apparent, located at the tip of the dialysis catheter intravenously.The pt underwent removal of the wire at an outside facility.The retrieved wire had a notable bend and defect within its outer core.

• Brand Name: MAHURKAR, 12FRENCH / 13CM LENGTH
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5818710
• MDR Text Key: 50404615
• Report Number: MW5063611
• Device Sequence Number: 1
• Product Code: MSD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1602000128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR