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

Model Number 08714729323310

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2023

Event Type  malfunction  

Event Description

A 10f boston scientific nephrostomy tube was defective.We inserted it into patient with no issue but the [invalid] to lock the pigtail in place was not connected to the tube and the physician was able to pull the entire [invalid] completely out of the tube.We simply removed the defective tube over a wire and inserted a new tube.No complications to patient.Would like boston scientific to be notified of failed device.

• Brand Name: FLEXIMA NEPHROSTOMY CATHETER SYSTEM
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17127623
• MDR Text Key: 317224857
• Report Number: MW5118376
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2023

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: 08714729323310
• Device Catalogue Number: M001271800
• Device Lot Number: 31255144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male