MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	M0062502260
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to 04/01/2024 based on the date the manufacturer became aware of the event.Imdrf device code a020504 captures the reportable event of sterile packaging hole.
Event or Problem Description
It was reported that a navigator access sheath device was to be used during a ureteroscopy procedure.It was found that the package had a hole in the sterile packaging.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 04/01/2024 based on the date the manufacturer became aware of the event.Block h6: imdrf device code a020504 captures the reportable event of sterile packaging hole.Block h11: investigation results: the returned navigator was analyzed, and a visual evaluation noted that one unopened pouch returned, and no tears or holes were detected in the returned closed pouch.With all the available information, the reported event was not confirmed.Based on the investigation, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.A visual test shows that it was not possible to identify any evidence of either the alleged issue or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Based on analysis results, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a navigator access sheath device was to be used during a ureteroscopy procedure.It was found that the package had a hole in the sterile packaging.The procedure was completed with another of the same device with no patient complications.

• Brand Name: NAVIGATOR HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19210281
• Report Number: 2124215-2024-25391
• Device Sequence Number: 12788605
• Product Code: FED
• UDI-Device Identifier: 08714729837558
• UDI-Public: 08714729837558
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140323
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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 Expiration Date: 01/15/2026
• Device Model Number: M0062502260
• Device Catalogue Number: 250-226
• Device Lot Number: 0033219115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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