MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE

Model Number	390-320
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code a040506 captures the reportable event of the attached wire torquer was found to be damaged.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone baskets was used on a transurethral lithotomy (tul) procedure performed on (b)(6) 2023.During procedure, the attached wire torquer was found to be damaged.Another of the same device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a040506 captures the reportable event of the attached wire torquer was found to be damaged.Block h10: visual inspection of the returned device found that the white and blue heat shrink were accordioned.During the functional test, it was observed that the cone could not be closed.The reported complaint is confirmed.Based on all available information, it is most likely that the damage was caused during the test of the device with the use of excessive force or manipulation.When force was exerted, the white and blue sheath became accordioned ultimately making it difficult to properly close the coil.Therefore, the most probable root cause is unintended use error.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone baskets was used on a transurethral lithotomy (tul) procedure performed on (b)(6) 2023.During procedure, the attached wire torquer was found to be damaged.Another of the same device was used to complete the procedure.There were no patient complications as a result of this event.Investigation results revealed the sheath bucked accordion; therefore, this is now a non mdr reportable event (see block h10 for investigation details).

• Brand Name: STONE CONE
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: carole morley morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16581934
• Report Number: 3005099803-2023-01438
• Device Sequence Number: 19228273
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 01/06/2025
• Device Model Number: 390-320
• Device Catalogue Number: 390-320
• Device Lot Number: 0006943658
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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