MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEPHROMAX SIZE: 30F X 12CM; HIGH PRESSURE NEPHROSTOMY BALLOON

Model Number M0062101420

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 04/08/2016

Event Type  Injury  

Event Description

During a nephrolithotripsy, surgeon recognized that the nephromax balloon had left a radiopaque metal circular fragment over the safety wire.This was a very small fragment, but was consistent with the tip of a nephromax balloon.It required an additional 45 minutes of surgical time to remove the object.

• Brand Name: NEPHROMAX SIZE: 30F X 12CM
• Type of Device: HIGH PRESSURE NEPHROSTOMY BALLOON
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5719862
• MDR Text Key: 47214160
• Report Number: MW5062767
• 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: 06/08/2016

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: Health Professional
• Device Model Number: M0062101420
• Device Lot Number: 18857096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR