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

Model Number	M0066703081
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event seal compromised.
Event or Problem Description
It was found that, when the device was removed from the packaging, the seal was compromised.The device was not used in the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event seal compromised.Correction to field g1: mfr contact last name.Correction to field g2: report source and report source (other).Block h11: investigation results: the sensor wire was returned inside its pouch for analysis.During inspection, it was noted that the pouch was opened at the top, which confirmed the reported event of a packaging seal compromised.A media analysis was performed, confirming the presence of the opened pouch containing the sensor wire.Based on the available information, it is probable that the damage to the pouch, including the separation of the seal, resulted from handling and manipulation during the shipping/receiving and/or storage processes.The device history record review was completed, and it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of packaging seal compromised was defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to transport/storage.
Event or Problem Description
It was found that, when the device was removed from the packaging, the seal was compromised.The device was not used in the procedure.

• 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: 23718183
• Report Number: 2124215-2025-89210
• Device Sequence Number: 10260145
• Product Code: EZB
• UDI-Device Identifier: 08714729302681
• UDI-Public: (01)08714729302681(17)280127(10)35720431
• 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): 03/08/2026

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: M0066703081
• Device Catalogue Number: 670-308
• Device Lot Number: 0035720431
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown