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

Model Number	M0062502230
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used during a ureteroscopy procedure performed on an unknown date.During the removal of the sheath after the procedure, it was noticed that the inner lining of the sheath was coming off and was coming of the sheath.The procedure was completed at this time.Reportedly, no piece of the device detached inside the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Device code a040506 captures the reportable issue of sheath peeled.Investigation result: one navigator device was received.Only the sheath was returned and it was bent.The dilator was not returned.It was also noted that the inner lining of the sheath was received in a container.Based on the available information, it is possible that the procedural or anatomical factors encountered during it use could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to kink/bend the device, once the sheath is kinked/bent it can affect the overall performance of the device making additional devices/tools to rub the inner walls of the sheath and it can damage the inner lining of the sheath contributing with the event reported.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 hd access sheath was used during a ureteroscopy procedure performed on an unknown date.During the removal of the sheath after the procedure, it was noticed that the inner lining of the sheath was coming off and was coming of the sheath.The procedure was completed at this time.Reportedly, no piece of the device detached inside the patient.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: 12206527
• Report Number: 3005099803-2021-03707
• Device Sequence Number: 19926162
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 05/29/2023
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0027404503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1