MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR HD; CATHETER, UROLOGICAL

Model Number	M0062502210
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in the kidney during a uteroscopy procedure performed on an unknown date.During the procedure, the sheath was stiff and it was also noted that the distal part of the device was broken.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Device code a04 captures the reportable event of tip of the device was broken.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the kidney during a flexible ureteroscopy procedure performed on an unknown date.During preparation, the sheath was stiff and it was also noted that the distal part of the device was broken.The procedure was completed with another navigator hd access sheath.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 information received on april 12, 2023: it was clarified that the sheath was not damaged instead the locking tab of the inner dilator broke off from the rest of the device.Note: a photo submitted by the customer shows the locking tab of the inner dilator detached from the rest of the device.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 03/01/2023 based on the date the manufacturer became aware of the event.Block h2: additional information: block b5 (describe event or problem), d4 (lot number, expiration date), and h4 (manufacture date) have been updated based on the additional information received on april 3, 2023, and april 5, 2023.Block h11: correction: imdrf device code has been updated to a0401 to capture that this event will no longer be reportable.Corrected content in block a3 (sex), b5 (describe event or problem), e1 (initial reporter title) and h10 (additional mfr narrative ).

• Brand Name: NAVIGATOR HD
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16665546
• Report Number: 3005099803-2023-01747
• Device Sequence Number: 20326805
• Product Code: FED
• UDI-Device Identifier: 08714729839064
• UDI-Public: 08714729839064
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: 10/26/2023
• Device Model Number: M0062502210
• Device Catalogue Number: 250-221
• Device Lot Number: 0028272349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female