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

Model Number	M0062502250
Medical Device Problem Codes	Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of sheath break.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the renal pelvis during a percutaneous ureterolithotomy procedure performed on (b)(6) 2023.During the procedure, the sheath broke when inserted into the patient.Additionally, the inner dilator was bent.The procedure was completed with another navigator hd access sheath.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of sheath break.Block h10: investigation result- the returned navigator hd (sheath and dilator) device was analyzed, and a visual evaluation noted that the sheath was fractured in the middle, and a bending marks were observed on the fractured site indicating that the material was submitted to tension.Microscopic examination was performed and confirmed that the sheath was fractured in the middle.Additionally, whitened areas were observed at the fractured site, indicating that the material was submitted to tension.No other problems with the device were noted.The reported event of sheath break was confirmed.It is possible that operational factors encountered during the procedure, such as the interaction with an excessive force during the procedure such as a kind of tension over the sheath could have caused the fracture observed as well as the bending marks.Consequently, affecting the device performance and intended purpose.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.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the renal pelvis during a percutaneous ureterolithotomy procedure performed on may 17, 2023.During the procedure, the sheath broke when inserted into the patient.Additionally, the inner dilator was bent.The procedure was completed with another navigator hd access sheath.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: 17124483
• Report Number: 3005099803-2023-03057
• Device Sequence Number: 7435034
• Product Code: FED
• UDI-Device Identifier: 08714729837992
• UDI-Public: 08714729837992
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/25/2023

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: 01/02/2024
• Device Model Number: M0062502250
• Device Catalogue Number: 250-225
• Device Lot Number: 0028614611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2022
• 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: Unknown