MAUDE Adverse Event Report: RUSCH PEDIATRIC BALLOON CATHETER

Device Problems Failure to Advance (2524); Material Protrusion/Extrusion (2979)

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

Event Date 11/13/2016

Event Type  malfunction  

Event Description

Foley would not advance, after the foley was pulled out the guide wire was protruding through the tip.Therapy start date: (b)(6) 2016.Diagnosis or reason for use: urinary tract infection.Event abated after use stopped or dose reduced: yes.

• Brand Name: PEDIATRIC BALLOON CATHETER
• Type of Device: PEDIATRIC BALLOON CATHETER
• Manufacturer (Section D): RUSCH
• MDR Report Key: 6134991
• MDR Text Key: 61232470
• Report Number: MW5066377
• Device Sequence Number: 1
• Product Code: EZL
• 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: 11/28/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 MO
• Patient Weight: 11