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

Model Number	M0063903200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nitinol retrieval coil was about to be used during a ureteral calculi procedure.During unpacking, it was found that the end of the closure device was fractured and detached.Additionally, the device could not be changed from the basket back to the guidewire.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detached.
Event or Problem Description
It was reported that a nitinol retrieval coil was about to be used during a ureteral calculi procedure.During unpacking, it was found that the end of the closure device was fractured and detached.Additionally, the device could not be changed from the basket back to the guidewire.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of coil detached.Investigation results the returned stone cone was analyzed, and a visual evaluation noted that there were no damages to the coil, and just minor bumps were observed.There were no functional issues, and the device was able to open and close with no issues.Boston scientific concludes that the reported event was not confirmed as the analysis of the device did not identify any detachment or breakage on the device.Based on analysis results, an investigation conclusion code of no problem detected was assigned to this investigation.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19563803
• Report Number: 2124215-2024-36814
• Device Sequence Number: 17718624
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 09/12/2026
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0008618973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 62 KG