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

Model Number	M0062502230
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of sheath fractured.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2023.After activating the coating, the sheath was inserted into the patient; however, a cracking sound was heard during insertion.When inspected outside the patient, it was found that the sheath was broken.The procedure was completed with another navigator hd access sheath.Note: the photos submitted by the customer show the sheath was fractured and the fractured site was slightly bent.It could also be observed that there were whitened areas adjacent to the fractured site, indicating that the material was submitted to tension.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be good.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2023.After activating the coating, the sheath was inserted into the patient; however, a cracking sound was heard during insertion.When inspected outside the patient, it was found that the sheath was broken and it could also be observed that there were whitened areas adjacent to the fractured site, indicating that the material was submitted to tension.The procedure was completed with another navigator hd access sheath.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: imdrf device code: a0414 captures the reportable event of sheath fractured.Block h10: investigation result: the returned navigator device was analyzed, and a visual evaluation noted that the sheath was fractured.Microscopic examination was performed, and it was noticed in the fracture site that the device was slightly bent, and whitened areas were observed adjacent to the fracture site, indicating that the material was submitted to tension.Based on the available information, it is possible that the reported sheath fracture could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device and operational factors during their use could have led to bend and cause the whitened areas on the sheath.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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17334030
• Report Number: 3005099803-2023-03707
• Device Sequence Number: 20736455
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• 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): 11/01/2023

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: 08/04/2023
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0027780515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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 Age: 67 YR
• Patient Sex: Male