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

Model Number	M0066703051
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a0501 captures the reportable event of shrink sleeve detached.Block h10: the returned sensor wire was analyzed.Upon visual assessment, it was observed that there was no peeled area nor detached sections at the tip, therefore, the tip detachment could not be confirmed.However, it was noted that the blue sleeve at the proximal section was detached, and it was not returned for analysis.Additionally, no core wire fracture was identified.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of tip detachment of device or device component was not confirmed during the product investigation, and therefore, no problem detected is associated with the tip detachment.Additionally, the blue sleeve was found to be detached.Based on the condition of the returned device, it is probable that the problem occurred due to procedural or anatomical factors encountered, handling, manipulation of the device and interaction on additional devices/tools, causing the separation of the sleeve.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used during a flexible mirror surgery to retrograde intrarenal surgery performed on june 25, 2023.During the procedure, the coating of the sensor wire fell off inside the patient.The procedure was completed with a new sensor guidewire.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of a section of the blue sleeve at the proximal section of the sensor wire was detached.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17914218
• Report Number: 3005099803-2023-05337
• Device Sequence Number: 12643739
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: 08714729302650
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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: 09/05/2025
• Device Model Number: M0066703051
• Device Catalogue Number: 670-305
• Device Lot Number: 0030097442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG