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

Model Number	M0066703120
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001 captures the reportable event of aborted procedure.
Event or Problem Description
It was reported that, during a greenlight vaporization of the prostate procedure using a sensor wire, the coating was falling apart at the distal part leading the guidewire not to work well, and the procedure was not completed due to the patient's stenosis there were no patient complications reported.This event is being reported for an aborted procedure with a patient under sedation.
Additional Manufacturer Narrative
Block h6: impact code f1001 captures the reportable event of aborted procedure.Block h11: the returned sensor wire was analyzed, and the evaluation found that the sleeve detached and kinked at the distal part.During magnification, it was observed closely the distal and central part of the device peeled.The reported complaint was confirmed.Additionally, it was found that the device had the ptfe peeled.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 peel the ptfe from the sensor wire and also kink and detach the sleeve.Based on the analysis results, the most probable cause is "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported that, during a greenlight vaporization of the prostate procedure using a sensor wire, the coating was falling apart at the distal part leading the guidewire not to work well, and the procedure was not completed due to the patient's stenosis there were no patient complications reported.This event is being reported for an aborted procedure with a patient under sedation.

• 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: 19977895
• Report Number: 2124215-2024-49644
• Device Sequence Number: 7115544
• Product Code: EZB
• UDI-Device Identifier: 08714729376385
• UDI-Public: 08714729376385
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: M0066703120
• Device Catalogue Number: 670-312
• Device Lot Number: 0033257624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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