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

Model Number	M0066703091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: the exact age of the patient is unknown.However, it was reported the patient was over 18 years old.Block d4, h4: the customer reported this could be one of three lot numbers 31128469, 31133485, and 31075347.It is unknown which of these lot numbers the tip broke off of.Block e4: this event was reported to the fda via a voluntary medwatch report.The report number is (b)(4).Block h6 (device codes): imdrf device code a0401 captures the reportable event of corewire break.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used in the kidney during an endoscopy procedure performed on (b)(6) 2023.During the procedure, the tip of the sensor wire broke off.The patient will require another procedure to remove the stone and the fragment that broke off will be retrieved at that time.
Additional Manufacturer Narrative
A2: the exact age of the patient is unknown.However, it was reported the patient was over 18 years old.D4, h4: the customer reported this could be one of three lot numbers 31128469, 31133485, and 31075347.It is unknown which of these lot numbers the tip broke off of.E4: this event was reported to the fda via a voluntary medwatch report.The report number is mw5117299.H6 (device codes): imdrf device code a0401 captures the reportable event of corewire break.H11: correction.D4 expiration date has been updated from required to not applicable.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used in the kidney during an endoscopy procedure performed on (b)(6) 2023.During the procedure, the tip of the sensor wire broke off.The patient will require another procedure to remove the stone and the fragment that broke off will be retrieved at that time.

• 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: 17070229
• Report Number: 3005099803-2023-02903
• Device Sequence Number: 5885820
• Product Code: EZB
• UDI-Device Identifier: 08714729257318
• UDI-Public: 08714729257318
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2026
• Device Model Number: M0066703091
• Device Catalogue Number: 670-309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female