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

Model Number	M0063903100
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on an unknown date.During procedure, the distal tip of the sheath was damaged during laser radiation.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Initial reporter name and address: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Initial reporter name and address: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on an unknown date.During procedure, the distal tip of the sheath was damaged during laser radiation.No patient complications were reported due to this event.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on an unknown date.During procedure, the distal tip of the sheath was damaged during laser radiation.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Block e1: initial reporter city is (b)(6).Block h6: device code a0401 was used to capture the reportable event of distal section of sheath break.Block h10: the returned stone cone was analyzed, and a visual analysis found the coil was detached at the distal end.The detached coil was not returned.There were burn marks and signs of laser damage at/near the spot where the coil was detached.The reported event was confirmed.The instructions for use (ifu) warns the user "do not fire upon the device with a laser." however, the analyzed device provides clear evidence that it was fired upon by the laser.Based on all available information, the most probable root cause is unintended use error, indicating that interaction between the user and the device caused or contributed to the error.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Additional Manufacturer Narrative
Correction: block g1 mfr site address 1 and h6 device code have been updated.Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Block e1: initial reporter city is shimonoseki, yamaguchi prefecture.Block h6: device code a0401 was used to capture the reportable event of distal section of sheath break.Block h10: the returned stone cone was analyzed, and a visual analysis found the the coil was detached at the distal end.The detached coil was not returned.There were burn marks and signs of laser damage at/near the spot where the coil was detached.The reported event was confirmed.The instructions for use (ifu) warns the user "do not fire upon the device with a laser." however, the analyzed device provides clear evidence that it was fired upon by the laser.Based on all available information, the most probable root cause is unintended use error, indicating that interaction between the user and the device caused or contributed to the error.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 nitinol retrieval coil was used in the ureter during a transurethral lithotripsy procedure performed on an unknown date.During procedure, the distal tip of the sheath was damaged during laser radiation.No patient complications were reported due to this event.

• 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 ; 5086834015
• MDR Report Key: 13196602
• Report Number: 3005099803-2022-00008
• Device Sequence Number: 4315244
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2026

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: M0063903100
• Device Catalogue Number: 390-310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 03/25/2022; 04/02/2026
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 04/11/2022; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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