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

Model Number M0062502250

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2016

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a navigator¿ hd access sheath was used during a ureteroscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the scope was caught at the tip of the sheath during retrieval of the flexible ureteroscope.The sheath was removed together with the scope and causes damaged to the scope.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: NAVIGATOR¿ HD
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5650581
• MDR Text Key: 45063044
• Report Number: 3005099803-2016-01347
• Device Sequence Number: 1
• Product Code: FED
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: M0062502250
• Device Catalogue Number: 250-225
• Device Lot Number: 17811470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1