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

Model Number	M0062502220
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in the right ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2023.During preparation, it was noticed that the tip of the sheath was bent.The procedure was completed with another navigator access sheath device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in the right ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2023.During preparation, it was noticed that the tip of the sheath was bent.The procedure was completed with another navigator access sheath device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h2: additional information: block d7a (sud reprocessed and reused) and block h8 (usage of device) updated.Block h6: imdrf device code a04 captures the reportable event of sheath tip bent.Block h10: investigation results the returned navigator was analyzed.A visual and microscopic examination found that the dilator tip was bent/kinked.Functional inspection was attempted to remove and insert the dilator in the sheath without any issues.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of sheath bent was confirmed.It is possible that operational factors, interaction of the excess force applied over the device during preparation such as the handling before their use could have caused the bent/kinked found.Therefore, the most probable root cause is adverse event related to procedure.

• 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: 16236106
• Report Number: 3005099803-2023-00201
• Device Sequence Number: 6405863
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/15/2023

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: 07/24/2024
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0029826962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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: Female