MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER NAVIGATOR¿ HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	M0062502280
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the complaint device revealed that the dilator and sheath were bent in the middle and the inner lining of the sheath was protruding out of the sheath tip.The noted failure likely occurred due to anatomical or procedural factors which limited the performance of the balloon.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 other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the upper ureter during a urinary tract stone removal procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the sheath inner coating from the tip was peeled off.It was reported that no parts of the device fell into the patient.The procedure was completed with another navigator hd 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.Investigation results showed that the inner liner of the sheath peeled off; therefore, this is now an mdr reportable event.

• Brand Name: NAVIGATOR¿ HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7070388
• Report Number: 3005099803-2017-03523
• Device Sequence Number: 1004666
• Product Code: FED
• UDI-Device Identifier: 08714729839088
• UDI-Public: 08714729839088
• Combination Product (Y/N): N
• PMA/510(K) Number: K122649
• 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
• Report Date (Section B): 11/13/2017

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: 10/31/2018
• Device Model Number: M0062502280
• Device Catalogue Number: 250-228
• Device Lot Number: 19839237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1