MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063901020
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a zero tip basket was about to be used during a ureterorenoscopy (urs) procedure performed on (b)(6), 2023.Prior to the procedure, upon checking the basket it was found that the tip was broken and completely detached.The procedure was completed with another zero tip basket device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire completely detached from the basket.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire completely detached from the basket.H10: investigation results: the returned zero tip baskets was analyzed, and a visual evaluation noted that the sheath was detached from the handle cannula.The basket wires were in good condition.Functional inspection was not performed due to condition of the device.With all the information available the reported event of basket wire detachment could not be confirmed.Based on the investigation it was found that the sheath is detached from the handle cannula.This could be related to handling and manipulation of the device prior procedure; it is probable that an excess of force applied to the device which could lead to detach the sheath from the handle cannula.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications, no abnormalities were reported during the assembly process.It was not possible to identify any evidence of the alleged issue.Therefore, the most probable cause of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip basket was about to be used during a ureterorenoscopy (urs) procedure performed on (b)(6) 2023.Prior to the procedure, upon checking the basket it was found that the tip was broken and completely detached.The procedure was completed with another zero tip basket device.There were no patient complications reported as a result of this event.

• Brand Name: ZERO TIP
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• 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: 18250151
• Report Number: 2124215-2023-67488
• Device Sequence Number: 6685660
• Product Code: FFL
• UDI-Device Identifier: 08714729342014
• UDI-Public: 08714729342014
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/03/2024

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 Expiration Date: 04/17/2026
• Device Model Number: M0063901020
• Device Catalogue Number: 390-102
• Device Lot Number: 0031450927
• 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: 11/11/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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