MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA NEPHROSTOMY CATHETER SYSTEM WITH DISSOLVING T; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Catalog Number M001281800

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2021

Event Type  malfunction  

Event Description

During an insertion of a nephrostomy tube the tapered tip dislodged, required another catheter same size, it too dislodged the tapered tip.No danger to the patient as the tips are dissolvable.

• Brand Name: FLEXIMA NEPHROSTOMY CATHETER SYSTEM WITH DISSOLVING T
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12016448
• MDR Text Key: 257197405
• Report Number: MW5101934
• Device Sequence Number: 1
• Product Code: GBO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2021
• 2 Devices were Involved in the Event: 1 2

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
• Device Expiration Date: 11/07/2023
• Device Catalogue Number: M001281800
• Device Lot Number: 26321546
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR