MAUDE Adverse Event Report: BOSTON SCIENTIFIC FLEXIMA CATHETER

Model Number M001271800

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 11/11/2013

Event Type  Injury  

Event Description

Boston scientific flexima cath item (b)(4) was removed in clinic, but somehow it malfunctioned and the black string was left behind.This was not noticed for almost a year and patient had worsening symptoms, pain, and ultimately an infection.Once it was removed then the patient began to feel better and his symptoms resolved.According to our urologists this should not happen.

• Brand Name: FLEXIMA CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 4190301
• MDR Text Key: 15997096
• Report Number: MW5038696
• Device Sequence Number: 1
• Product Code: FFA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M001271800
• Device Lot Number: NK
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR