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

Model Number	M0062502260
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in the ureter during a transurethral stone crushing procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that one-fifth of the sheath tip appeared to be missing.Also, the tip was not in a circular shape.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 2978 captures the reportable issue of tip damaged.Block h10: investigation results a visual examination of the returned device found that the sheath and dilator tip were rounded and properly made.A physical examination of the device found that the sheath and dilator kinked in the middle.It was also noticed that the sheath tip and dilator tip presented some scratches.This failure is likely due to factors encountered during the procedure, such as handling or manipulation that could have lead to kink/bent the device, also the access sheath is to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, therefore it is likely that interaction with different devices/tools/instruments could have contributed with the scratches observed on the sheath and dilator tip.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 was used in the ureter during a transurethral stone crushing procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that one-fifth of the sheath tip appeared to be missing.Also, the tip was not in a circular shape.The procedure was completed with another navigator 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
• MDR Report Key: 10717328
• Report Number: 3005099803-2020-04877
• Device Sequence Number: 3141076
• Product Code: FED
• UDI-Device Identifier: 08714729837558
• UDI-Public: 08714729837558
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140323
• 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,Followup
• Report Date (Section B): 12/17/2020

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: 06/03/2022
• Device Model Number: M0062502260
• Device Catalogue Number: 250-226
• Device Lot Number: 0025559723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1