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

Model Number	M0066703050
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a0401 captures the reportable investigation results of core wire detached/separated.Block h10: the returned sensor wire was analyzed, and upon visual inspection, it was observed that the coil unraveled and peeled, and the wire was detached.During magnification, there were marks observed in the coil and core wire surface indicating that there was an unknown interaction with an unknown tool or equipment.No other problems with the device were noted.With all the available information, boston scientific concludes that the reported event of guidewire unraveled, and guide wire peeled was confirmed.It is possible to conclude that it may be related with an excess of force pulling out the device once the detachment was generated leading the coil to be unraveled, additionally, while the device was getting out the interaction between the guide wire and the endoscope could have been generated the peeled.Based on the information available and investigation results, a conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used during a ureteroscopic lithotripsy procedure in the ureter performed on (b)(6), 2023.During the procedure, when the guidewire was removed from the endoscope, it was found that the outer layer was peeled.The procedure was successfully completed with another sensor wire.There were no patient complications reported as a result of this event.Investigation results revealed that the core wire was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

• 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: 18483567
• Report Number: 2124215-2024-00622
• Device Sequence Number: 15735252
• Product Code: EZB
• UDI-Device Identifier: 08714729376354
• UDI-Public: 08714729376354
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 01/10/2024

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 Model Number: M0066703050
• Device Catalogue Number: 670-305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/10/2024
• 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