MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION URETERAL CATHETER; CATHETER, URETHRAL

Model Number	M0064002010
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6).2023 based on the date the manufacturer became aware of the event.Block h6: imdrf device code a020504 captures the reportable event of packaging torn.
Event or Problem Description
It was reported to boston scientific corporation that a flexima open end ureteral catheter device was about to be used in the ureteroscopy (urs) procedure on an unknown date.Prior to procedure, it was found that the product packaging was torn or rip, and because of that the product was no longer sterile.The procedure was completed with another flexima open end ureteral catheter device.There were no patient complications reported as a result of this event.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• 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 ; 5086834015
• MDR Report Key: 18155263
• Report Number: 2124215-2023-63509
• Device Sequence Number: 12402006
• Product Code: KOD
• UDI-Device Identifier: 08714729751571
• UDI-Public: 08714729751571
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K830840
• 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
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2026
• Device Model Number: M0064002010
• Device Catalogue Number: 400-201S
• Device Lot Number: 0032454104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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