MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IRRIGATION; CATHETER, UROLOGICAL

Model Number	M0067201010
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
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 e1: facility address: (b)(6).Block h6: imdrf device code a1802 captures the reportable event of foreign matter.
Event or Problem Description
It was reported to boston scientific corporation that a single action pump was to be used during a transurethral lithotripsy (tul) procedure performed on an unknown date.It was reported that the device was contaminated, and they found hair in the sterile packaging.The procedure was completed with another single action pump device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 12/01/2023 based on the date the manufacturer became aware of the event.Block e1: facility address: (b)(6).Block h6: imdrf device code a1802 captures the reportable event of foreign matter.Block h10: investigation result the returned irrigation device was analyzed, and a visual evaluation noted that evidence of a foreign matter was inside the pouch.Based on the available information, boston scientific concludes that the reported event was confirmed.After the analysis performed and the evidence found and due to problems traced to manufacturing process the most probable root cause is manufacturing deficiency.
Event or Problem Description
It was reported to boston scientific corporation that a single action pump was to be used during a transurethral lithotripsy (tul) procedure performed on an unknown date.It was reported that the device was contaminated, and they found hair in the sterile packaging.The procedure was completed with another single action pump device.There were no patient complications reported as a result of this event.

• Brand Name: IRRIGATION
• Common Device Name: CATHETER, UROLOGICAL
• 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: 18436955
• Report Number: 2124215-2023-74333
• Device Sequence Number: 20606115
• Product Code: KQT
• UDI-Device Identifier: 08714729752998
• UDI-Public: 08714729752998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K870557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 0031262265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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