MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0062502040
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual examination of the returned complaint device found that the sheath and the dilator were kinked at the proximal section.It was also noticed that the sheath was torn/damaged at the hub.Dimensional inspection of the sheaths inner diameter was performed using pin gages and it passed the test and was noted to be within specifications.This failure is likely due to factors or conditions related to the procedure during the use of the device, such as the manner in which the device was handled and manipulated that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used during a uterolithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the access sheath was introduced into the patient and it did not progress.The device was removed and it was noticed that it was damaged.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.Investigation results revealed that the sheath was torn; therefore, this is now an mdr reportable event.

• Brand Name: NAVIGATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10711018
• Report Number: 3005099803-2020-04835
• Device Sequence Number: 3259144
• Product Code: KOD
• UDI-Device Identifier: 08714729429968
• UDI-Public: 08714729429968
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

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: 08/05/2021
• Device Model Number: M0062502040
• Device Catalogue Number: 250-204
• Device Lot Number: 0024221018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1