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

Model Number	M0062502220
Medical Device Problem Codes	Peeled/Delaminated (1454); Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2023 based on the date the manufacturer became aware of the event.Block h6: imdrf device code a040506 captures the reportable event of sheath peeled.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used during a procedure performed on an unknown date.During the procedure, a portion of the sheath towards the middle still feels stick and not coated after the coating was activated.Additionally, after a few back and forth passes, it was noticed that the coating on the sheath started to flake off.The procedure was completed with another navigator hd access sheath.Note: a photo submitted by the customer shows that the coating of the outer sheath was not activated in several sections.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 07/01/2023 based on the date the manufacturer became aware of the event.Block h2: additional information: block b5 (describe event or problem) and block h6 (imdrf device code) have been updated to capture that this event will no longer be reportable based on the additional information received on august 21, 2023.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used during a procedure performed on an unknown date.During the procedure, a portion of the sheath towards the middle still feels stick and not coated after the coating was activated.Additionally, after a few back and forth passes, it was noticed that the coating on the sheath started to flake off.The procedure was completed with another navigator hd access sheath.Note: a photo submitted by the customer shows that the coating of the outer sheath was not activated in several sections.There were no patient complications reported as a result of this event.Additional information received on august 2, 2023.It was reported that it was the hydrophilic coating that flake off.

• 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
• 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: 17435783
• Report Number: 3005099803-2023-04143
• Device Sequence Number: 15674675
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 03/26/2025
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0031309505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2023
• 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: Unknown