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

Model Number	M0062502230
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was unpacked to be used in the pelvis calculi for a transureteroscopic holmium laser lithotripsy with luminal dilation procedure performed on (b)(6) 2021.While unpacking, it was noted that the tip of the device was tilted and could not be used.The procedure ws completed with another navigator access sheath.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h2: additional information: block e1 (initial reporter faciltity name, address, city/state and zip/post code), block h10 (additional narrative).This event was reported by the distributor.The physician is: dr.(b)(6).Phone: (b)(6).(b)(6) hospital (b)(6).China.Block h6: problem code a04 captures the reportable event of the tip of the device was tilted.Block h10: investigation result.A photo was submitted by the customer showing the navigator device with the dilator distal tip bent.A visual examination of the returned complaint device found that the distal tip was bent.Functional analysis was done and the dilator was removed and reinserted without any issues.Based on the available information, it is possible that the setup factors encountered during the preparation, such as handling manipulation, interaction with other device or an excess of force applied, could have caused these failures and consequently affect the performance of 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.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was unpacked to be used in the pelvis calculi for a transureteroscopic holmium laser lithotripsy with luminal dilation procedure performed on (b)(6) 2021.While unpacking, it was noted that the tip of the device was tilted and could not be used.The procedure ws completed with another navigator access sheath.There were no patient complications 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: 12511682
• Report Number: 3005099803-2021-04923
• Device Sequence Number: 14431562
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 02/23/2023
• Device Model Number: M0062502230
• Device Catalogue Number: 250-223
• Device Lot Number: 0026861418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65