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

Model Number	M0062502220
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: the returned navigator device was analyzed, and a visual evaluation noted that the sheath was broken at the middle section.It was also observed that the inner liner was complete and protrude from the sheath.Microscopic examination was performed and the device was observed before moistened with water and after moistened, it was found that different sections (voids) of the sheath without coating.A functional evaluation was performed by moistening the sheath and dilator surfaces with water, the dilator became slippery indicating coating was applied to the dilator and the proximal end of the sheath became slippery without problems; however, some stiffness was felt in some areas of the distal end of the sheath.Dimensional test cannot be performed due to the unit returned with a blue tape covering the uncoated section of the sheath.No other problems with the device were noted.Taking all available information into consideration, the device met all manufacturing specifications required and no abnormalities were reported during the assembly process.However, it is possible that the device had interaction with a stone, leading to the found problem of balloon torn longitudinally.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was not performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the ureter during a flexible ureteroscopy (furs) procedure performed on (b)(6) 2022.During the procedure, the hydrophilic coating of the device has come off.The procedure was completed with another navigator hd access sheath device.This event has been deemed a reportable event based on the investigation finding of sheath break.Please see device analysis results for full investigation details.There were no patient complications reported as a result of this event.

• 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: 14160370
• Report Number: 3005099803-2022-02020
• Device Sequence Number: 14855101
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 06/16/2023
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0027503497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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