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

Model Number	M0062502220
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 device was used during a soft ureteroscopic lithotomy procedure performed on (b)(6) 2021.During unpacking, the working length of the sheath was found broken in two separate pieces.The procedure was completed with another navigator hd access sheath device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath device was used during a soft ureteroscopic lithotomy procedure performed on (b)(6) 2021.During unpacking, the working length of the sheath was found broken in two separate pieces.The procedure was completed with another navigator hd access sheath device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: device code a0401 captures the reportable issue of sheath broken.Block h10: investigation result a visual examination of the returned complaint device found that one navigator was received with the hoop torn from the sheath, which confirms the reported event.No other problem noted such as bends or kinks on the device.Based on the available information, the failure of hoop torn from the sheath could have been caused by the user during the preparation/inspection of the device after unpacking.An excess of force during the withdrawal or advancing of the dilator through the sheath could affect the device performance.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: 12280246
• Report Number: 3005099803-2021-04009
• Device Sequence Number: 19715893
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 12/04/2022
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0026464025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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