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

Model Number	M0062502220
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 as the event date is unknown.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used during a ureteroscopy (urs) procedure performed on an unknown date.During the procedure, while inserting the sheath it was noted that the sheath broke.Reportedly, there were no pieces left inside the patient.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used during a ureteroscopy (urs) procedure performed on an unknown date.During the procedure, while inserting the sheath it was noted that the sheath broke.Reportedly, there were no pieces left inside the patient.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 b3: date of event was approximated to (b)(6) 2021 as the event date is unknown.Block h6: medical device problem code a0414 captures the reportable issue of sheath broke.Block h10: investigation result: one navigator was returned for analysis.A visual examination of the returned device found that the sheath and dilator were bent.A functional inspection was performed and the device sheath and dilator surfaces were moistened with water and it became slippery, indicating that the coating was applied on both devices, the reported complaint was not confirmed.No other issues with the devices were noted.This failure is likely due to factors or conditions related to procedure during the use of the device, such as generated by the user or during the interaction with the device, also, an excess of force during the withdrawal or advancing into the anatomy of the patient and the technic of the physician could cause the bend in the device.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.

• 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: 12294780
• Report Number: 3005099803-2021-04054
• Device Sequence Number: 3180932
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 03/11/2023
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0026956253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1