MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0062502020
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was reported by the distributor.(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used during a procedure performed on (b)(6) 2021.It was reported that the internal lining of the sheath was peeling.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used during a procedure performed on october 5, 2021.It was reported that the internal lining of the sheath was peeling.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Section e: this event was reported by the distributor.The health care facility name is: serv social da ind do papel papelao e cort do est de sp block h6: medical device problem code a040506 captures the reportable event of sheath peeled.Block h10: investigation result the returned navigator device was analyzed, and a visual evaluation noted that the returned sheath and dilator were in good shape.Functional evaluation was performed by moistening both sheath and dilator surfaces with water.However, the sheath did not became slippery.Additionally, some stiffness was felt in some areas of the distal end of the sheath.Microscopic examination was performed by observing the device before moistened with water and after moistened with water, and it was found some void in the coating of the sheath.The inner liner was also present on the device and was in a good shape.Dimensional analysis was performed on the sheath uncoated section and the length of the coating.The uncoated section was found to be within specification and the length of the coating was found to be out of specification.No other problems with the device were noted.Based on the condition of the returned device, the reported event of internal peeling was not confirmed.Investigation found that the inner liner was in a good condition and no problems were noted.The returned device review showed no evidence of either the alleged or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint cannot be detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: NAVIGATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• 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: 12759229
• Report Number: 3005099803-2021-05719
• Device Sequence Number: 3343314
• Product Code: KOD
• UDI-Device Identifier: 08714729429944
• UDI-Public: 08714729429944
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030956
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 05/24/2023
• Device Model Number: M0062502020
• Device Catalogue Number: 250-202
• Device Lot Number: 0027366770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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