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

Model Number	M0062502230
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: device code a0414 captures the reportable event of sheath torn.
Event or Problem Description
It was reported that during a ureteroscopic lithotripsy procedure, when the navigator access sheath was about to be inserted, it was observed fractured.The procedure was completed with another of the same device with no patient complications.
Event or Problem Description
It was reported that during a ureteroscopic lithotripsy procedure, when the navigator access sheath was about to be inserted, it was observed fractured.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: device code a0414 captures the reportable event of sheath torn.Block h11: investigation results the returned navigator with both sheath and dilator were analyzed, and a visual evaluation noted that the dilator tip returned in good condition; however, it was noticed that the dilator was bent/kinked.Media analysis was performed from the pictures provided by the customer, and it showed that the navigator access sheath was broken (fully detached in three pieces).Microscopic examination of returned device was performed under magnification, and it was possible to see that the sheath was broken.Additionally, the sheath was fully detached in three pieces; however, it was not possible to identify any torn on the device.With all the available information, boston scientific concludes that the reported event of sheath torn material was not confirmed since there was no evidence of any torn on the device.Based on the investigation results, the observed damage could be related to handling and manipulation of the device during procedure since as per customer information the sheath was fractured when it was about to be implanted, it is probable that an excess of force applied to the device such as operational factors during their use could cause the issues observed.The instructions for use states not to bend or kink the dilator or sheath prior to placement; to do so could damage the integrity of the device.Based on information available and analysis results, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 20487175
• Report Number: 2124215-2024-65277
• Device Sequence Number: 11666505
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 01/11/2026
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0033196999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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: Male