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

Model Number	M0062502020
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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 mdr 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 an unknown date.According to the complainant, during the procedure, it was noted that the sheath was apparently fraying internally.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: problem code 1454 captures the reportable event of sheath peeled.Block h10: 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 mdr 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 an unknown date.According to the complainant, during the procedure, it was noted that the sheath was apparently fraying internally.The procedure was completed at this time.There were no patient complications reported as a result of this event.***additional information received on (b)(6) 2020*** it was reported that the procedure was performed on (b)(6)2019.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: NAVIGATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9529785
• Report Number: 3005099803-2019-06334
• Device Sequence Number: 2460817
• Product Code: KOD
• UDI-Device Identifier: 08714729429944
• UDI-Public: 08714729429944
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 05/21/2021
• Device Model Number: M0062502020
• Device Catalogue Number: 250-202
• Device Lot Number: 0023834158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1