MAUDE Adverse Event Report: BOSTON SCI MALECOT NEPHROSTOMY

Model Number 410-106

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

Nephrostomy catheter tube was placed (b)(6) and pt was brought back for a second look for a percutaneous nephrectomy, found that the catheter was broken.Wong removed the broken pieces in the patient.

• Brand Name: MALECOT NEPHROSTOMY
• Type of Device: MALECOT NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCI; spencer IN 47460
• MDR Report Key: 4745459
• MDR Text Key: 5827982
• Report Number: MW5042442
• Device Sequence Number: 1
• Product Code: LJE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 410-106
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR