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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Problem code for the reportable issue of sheath coating peeling.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 the ureter/kidney during a flexible urs procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the sheath was inserted it was noticed that a piece of plastic is on top of the sheath.Reportedly, the piece of plastic detached inside the patient.The detached piece was attempted to be removed using a 1.9f basket but was unsuccessful and was left to pass naturally.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient was reported to have recovered well.
Additional Manufacturer Narrative
(b)(4).A visual examination of the returned complaint device found that both the dilator and sheath were bent in the middle.It was also noted that a material was placed at the tip of the device which is visually consistent to the remnants of the inner liner of the sheath.This failure is likely due to adverse factors and/or conditions related to the procedure during the use of the device which limited the performance of the device.Therefore, the most probable root cause is cause traced to component failure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in the ureter/kidney during a flexible urs procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the sheath was inserted it was noticed that a piece of plastic is on top of the sheath.Reportedly, the piece of plastic detached inside the patient.The detached piece was attempted to be removed using a 1.9f basket but was unsuccessful and was left to pass naturally.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient was reported to have recovered well.

• Brand Name: NAVIGATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 7850241
• Report Number: 3005099803-2018-60291
• Device Sequence Number: 13918798
• Product Code: KOD
• UDI-Device Identifier: 08714729429968
• UDI-Public: 08714729429968
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2020
• Device Model Number: M0062502040
• Device Catalogue Number: 70385
• Device Lot Number: 0022146657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention