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

Model Number M0064101030

Device Problem Break (1069)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of catheter break.

Event Description

It was reported to boston scientific corporation that a malecot nephrostomy catheter device was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2024.During the procedure, one of the catheter flair ripped while inserting the stylet to straighten the catheter.The procedure was completed with another malecot nephrostomy catheter device.There were no patient complications reported as a result of this event.

• Brand Name: MALECOT NEPHROSTOMY CATHETERS
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18937854
• MDR Text Key: 338071686
• Report Number: 2124215-2024-15814
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729005292
• UDI-Public: 08714729005292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

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: M0064101030
• Device Catalogue Number: 410-103
• Device Lot Number: 0032074542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1