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	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 cre navigator access sheath was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the sheath frayed and left a hair like sting loose in the sheath.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre navigator access sheath was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the sheath frayed and left a hair like sting loose in the sheath.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.**correction** it was reported to boston scientific corporation that a navigator access sheath was used in a procedure performed on (b)(6) 2019.
Additional Manufacturer Narrative
Block h6: problem code 1454 captures the reportable event of sheath peeled.Block h10: investigation results a visual examination of the returned complaint device found that both the sheath and dilator were bent.It was also noted that the inner lining of the sheath protruded from the tip of the sheath and the inner walls also had evidence of scratching.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.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
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9495355
• Report Number: 3005099803-2019-06187
• Device Sequence Number: 16447894
• Product Code: KOD
• UDI-Device Identifier: 08714729429944
• UDI-Public: 08714729429944
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K030956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 06/24/2021
• Device Model Number: M0062502020
• Device Catalogue Number: 250-202
• Device Lot Number: 0024009799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR