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

Model Number	M0062502230
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that navigator hd device was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2022.During the procedure, the sheath appeared brittle and broke in multiple places.Reportedly, the wire inside the sheath made it possible to easily retrieve the fragments.The procedure was completed with the use of another sheath.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Date of event was approximated to be (b)(6) 2022 based on the date the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 hd access sheath device was used during a ureteroscopy procedure performed on (b)(6) 2022.During the procedure, the sheath appeared brittle and broke in multiple pieces but remained attached to the coil wire.It was reported that the wire inside the sheath was pulled out slowly which made it possible to easily retrieve the fragments.The procedure was completed with another sheath.There were no patient complications have been reported due to this event.
Additional Manufacturer Narrative
Block h6: medical device code a0414 captures the reportable event of sheath appeared brittle and broke.Block h10: investigation result.The returned navigator hd device was analyzed, and a visual evaluation noted that only the sheath was returned.The inner dilator was not returned with the device.The sheath was torn along the working length and the inner coil wire was stretched out.A functional evaluation could not be performed due to the condition of the device (sheath was torn and bent).Microscopic examination was performed and it was found that the sheath had bending marks.No other problems with the device were noted.The reported event of sheath break was confirmed.It is possible that factors encountered during the procedure, such as handling and manipulation of the device during use could have caused the found problem of sheath torn and stretch marks on the sheath.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: correction: block b3 (date of event), b5 (describe event or problem) and h10 (additional mfr narrative).

• 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: 14602000
• Report Number: 3005099803-2022-03049
• Device Sequence Number: 14712582
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 07/13/2022

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: 06/26/2023
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0027564348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2021
• 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