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

Model Number	M0062502220
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a040506 captures the reportable event of sheath peeled.
Event or Problem Description
It was reported that during the procedure a navigator access sheath device was used with a flexible endoscope; however, an abrasion of the coating was found inside the sheath.The detached vinyl was retrieved from inside the sheath using a forceps and it did not fell off inside the patient.The procedure was completed with another of the same device without patient complications.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: a hospital of university of occupational and environmental health block h6: imdrf device code a040506 captures the reportable event of sheath peeled.Block h11: investigation result the returned navigator device was analyzed, and a visual evaluation noted that the inner lining detached/separated from the navigator sheath.Microscopic examination was performed, and sheath returned broken at the proximal section.Additionally, there was evidence of whitened areas near the breakage indicating the device was submitted to tension.With all the available information, boston scientific concludes that the reported event of sheath peeled was confirmed.It is possible that the reported sheath broken could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during the use could broke the sheath.Additionally, the navigator was used with a flexible endoscope, it is possible that operational factors, interaction/handling with the flexible endoscope during the procedure could have led to reported sheath peeled.Based on the analysis results, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure a navigator access sheath device was used with a flexible endoscope; however, an abrasion of the coating was found inside the sheath.The detached vinyl was retrieved from inside the sheath using a forceps and it did not fell off inside the patient.The procedure was completed with another of the same device without 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: 19702874
• Report Number: 2124215-2024-41785
• Device Sequence Number: 18072401
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/19/2024

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: 01/08/2026
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0033169064
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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