MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSOR; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066703050
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	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used to treat kidney stones during a percutaneous nephrolithotomy procedure performed on (b)(6) 2024.After completion of the procedure successfully with the sensor guidewire, when the physician performed final check with the ureteroscope, a plastic sheath (sleeve) of the guidewire was observed to be detached.The plastic sheath was removed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.Update to block g2: costa rica block h10: the returned sensor wire was analyzed, and upon magnification it was observed that the ptfe peeled in different sections of the coil and the sleeve was fully detached.No other problems with the device were noted.The reported event was confirmed.With all the available information, boston scientific concludes that the reported event was confirmed.It is possible that this could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to detach the sleeve and cause the peeling on the ptfe.Based on the information available and analysis results, a conclusion code of adverse event related to procedure has been assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used to treat kidney stones during a percutaneous nephrolithotomy procedure performed on (b)(6) 2024.After completion of the procedure successfully with the sensor guidewire, when the physician performed final check with the ureteroscope, a plastic sheath (sleeve) of the guidewire was observed to be detached.The plastic sheath was removed.There were no patient complications reported as a result of this event.

• Brand Name: SENSOR
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18654052
• Report Number: 2124215-2024-06192
• Device Sequence Number: 20881072
• Product Code: EZB
• UDI-Device Identifier: 08714729376354
• UDI-Public: 08714729376354
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 04/01/2024

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: 09/10/2026
• Device Model Number: M0066703050
• Device Catalogue Number: 670-305
• Device Lot Number: 0032399869
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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: 38 YR
• Patient Sex: Male