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

Model Number	M0062502220
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used during a ureteral lithotomy procedure performed on (b)(6) 2023.During the procedure, upon opening the package it was found that there was a small hole in the inner packing.Additionally, the goods had bacteria and the seal has been compromised.The procedure was completed with another navigator access sheath device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a020504 captures the reportable event of a small hole in the inner packing.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used during a ureteral lithotomy procedure performed on (b)(6) 2023.During the procedure, upon opening the package it was found that there was a small hole in the inner packing.Additionally, the goods had bacteria and the seal has been compromised.The procedure was completed with another navigator access sheath device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a020504 captures the reportable event of a small hole in the inner packing.Block h10: investigation results the returned navigator hd device was analyzed, and a visual evaluation noted that the device returned in its sealed pouch.Microscopic examination was performed, and a small hole was observed in the back side of the pouch.Damage in the pouch was coincident with the position of the device inside the package.Per device history review (dhr), it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.With all the available information, boston scientific concludes that the investigation findings did not lead to a clear conclusion about the cause of the observed failure.Therefore, the most probable root cause is cause not established.

• 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: 17650080
• Report Number: 3005099803-2023-04665
• Device Sequence Number: 7502661
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/08/2023

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: 10/09/2024
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0030313006
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 68 KG