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

Model Number	M0067201010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a single action pumping system device was used in the ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6), 2022.During the procedure, the body of the syringe got broken and a broken part got stuck inside the syringe.It was reported that the physician got hurt by the broken edge of the syringe and was treated with bandage compression.The procedure was not completed due to this event.The physician's current condition was reported to be good with no complications.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a single action pumping system device was used in the ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6) 2022.During the procedure, the body of the syringe got broken and a broken part got stuck inside the syringe.It was reported that the physician got hurt by the broken edge of the syringe and was treated with bandage compression.The procedure was not completed due to this event.The physician's current condition was reported to be good with no complications.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Investigation results: the returned single action pumping system was analyzed, and a visual evaluation noted that the syringe was not attached to the dual check valve luer lock.The roller clamp was returned in an open position and the tubing set was free from obvious kinks.Additionally, the thumb tab was broken, and the broken part was not returned with the device.Microscopic examination was performed, and it was found that the crimp placement of the thumb tab was in placed.Functional evaluation could not be performed due to the condition of the returned device.No other problems with the device were noted.The reported event was confirmed.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15561474
• Report Number: 3005099803-2022-05665
• Device Sequence Number: 5861747
• Product Code: KQT
• UDI-Device Identifier: 08714729045076
• 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): 12/07/2022

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: 04/17/2026
• Device Model Number: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 0029237547
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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