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

Model Number	M0062502220
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two navigator hd access sheath devices used in the same patient and procedure.It was reported to boston scientific corporation that two navigator hd access sheath devices were used in the kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the plastic part of the sheath broke when the scope was passed through the device.The same issue occurred with the second navigator hd access sheath.The procedure was completed with another navigator hd access sheath devices.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of two navigator hd access sheath devices used in the same patient and procedure.It was reported to boston scientific corporation that two navigator hd access sheath devices were used in the kidney during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the plastic part of the sheath broke when the scope was passed through the device.The same issue occurred with the second navigator hd access sheath.The procedure was completed with another navigator hd access sheath devices.There were no patient complications reported as a result of this event.Additional information received on october 21, 2021: it was clarified that it was the white proximal hub of the device which was broken.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12623151
• Report Number: 3005099803-2021-05278
• Device Sequence Number: 1402289
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: M0062502220
• Device Catalogue Number: 250-222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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