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

Model Number	M0062502220
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of a ureterolitotomia procedure, when the device was unpacked, it was found that the outer sheath of the navigator was fractured.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
H6: device code a0414 captures the reportable event of sheath torn.Block h11: investigation results the product was not returned for analysis therefore technical analysis could not be performed; however, media analysis shows that the navigator hd had the sheath torn and it is possible to see some whitened areas indicating it was submitted to tension.With all the available information, boston scientific concludes that the reported event of sheath torn material was confirmed.This could be related to handling and manipulation of the device during preparation, it is probable that an excess of force applied to the device such as operational factors could lead to tear the sheath.Additionally, it was possible to see some whitened areas indicating it was submitted to tension.Based on the analysis results, a conclusion code of adverse event related to procedure was assigned to this investigation because the adverse event occurred during the procedure and the device had no influence on the event.
Additional Manufacturer Narrative
Block h2: correction on b3 (event date).Block h6: device code a0414 captures the reportable event of sheath torn.Block h11: investigation results: the product was not returned for analysis therefore technical analysis could not be performed; however, media analysis shows that the navigator hd had the sheath torn and it is possible to see some whitened areas indicating it was submitted to tension.With all the available information, boston scientific concludes that the reported event of sheath torn material was confirmed.This could be related to handling and manipulation of the device during preparation, it is probable that an excess of force applied to the device such as operational factors could lead to tear the sheath.Additionally, it was possible to see some whitened areas indicating it was submitted to tension.Based on the analysis results, a conclusion code of adverse event related to procedure was assigned to this investigation because the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that during preparation of a ureterolitotomia procedure, when the device was unpacked, it was found that the outer sheath of the navigator was fractured.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: 20247376
• Report Number: 2124215-2024-57741
• Device Sequence Number: 7312277
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 10/09/2024

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: 03/12/2026
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0033614050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/09/2024
• Date Device Manufactured: 03/12/2024
• 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 Age: 57 YR
• Patient Sex: Male