MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER NAVIGATOR¿; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0062502031
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 navigator access sheath was used in the kidney during a ureteroscopy and laser lithotripsy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the inner lining of the device started to peel off/sheared exposing the metal coil.It was also reported that no parts detached from the sheath.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Visual examination of the returned navigator hd access sheath revealed that the dilator was bent in the middle, while the sheath was torn in several locations with the inner coil exposed in those sections and some sections of the sheath were broken.These failures likely occurred due to anatomical or procedural factors which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in the kidney during a ureteroscopy and laser lithotripsy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the inner lining of the device started to peel off/sheared exposing the metal coil.It was also reported that no parts detached from the sheath.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.The patient's 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 - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7052236
• Report Number: 3005099803-2017-03539
• Device Sequence Number: 1290061
• Product Code: KOG
• UDI-Device Identifier: 08714729469582
• UDI-Public: 08714729469582
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 10/27/2017

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: 02/28/2018
• Device Model Number: M0062502031
• Device Catalogue Number: 250-203
• Device Lot Number: 18962273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1