MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0062502040
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 in a procedure performed on (b)(6) 2021.During the procedure, an internal desquamation was noted on the device.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in a procedure performed on (b)(6) 2021.During the procedure, an internal desquamation was noted on the device.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: medical device problem code a040506 captures the reportable event of internal desquamation.Block h10: investigation results the returned navigator hd device was analyzed, and a visual evaluation noted that the sheath and the dilator were bent.A container was also returned with the internal lining of the sheath inside of it.Microscopic examination was performed and it was found that the internal diameter of the sheath had desquamation, thereby confirming the reported event.A functional evaluation was performed by reinserting the dilator through the sheath and no problems were observed.No other problems with the device were noted.The reported event was confirmed.It is possible that factors encountered during the procedure, such as handling and manipulation of the device during use could have caused the kinked found on the sheath.Once the sheath is kinked, additional devices or tools could rub the inner walls of the sheath and can damage the inner lining of the sheath which could have contributed to the reported event.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: NAVIGATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• 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: 12736525
• Report Number: 3005099803-2021-05715
• Device Sequence Number: 19865417
• Product Code: KOD
• UDI-Device Identifier: 08714729429968
• UDI-Public: 08714729429968
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030956
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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: 06/03/2023
• Device Model Number: M0062502040
• Device Catalogue Number: 250-204
• Device Lot Number: 0027429583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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: Unknown