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

Model Number	M0064101030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2024-15814
• Device Sequence Number: 6971597
• Product Code: GBO
• UDI-Device Identifier: 08714729005292
• UDI-Public: 08714729005292
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K820867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown