MAUDE Adverse Event Report: COVIDIEN NITREX GUIDEWIRE; WIRE, GUIDE, CATHETER

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)

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

Event Date 08/08/2016

Event Type  malfunction  

Event Description

During an interventional radiology procedure, nephrostomy tube placement.018 nitrex guidewire was passed into the renal collecting system, so difficulty passing the wire into the ureter due to obstruction from the some in the renal pelvic, upon withdrawal of the nitrex wire, a small fragment of the wire has sheard off the tip of the guidewire approx 3 cm length of coiled wire was broken off and embedded in the kidney.Attempts were made to snare the fragment.

• Brand Name: NITREX GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COVIDIEN; 4600 nathan ln. north; plymouth MN 55442
• MDR Report Key: 5979567
• MDR Text Key: 55744166
• Report Number: 5979567
• Device Sequence Number: 1
• Product Code: DQX
• 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: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2016
• Event Location: Other
• Date Report to Manufacturer: 09/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR