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

Model Number M0062502220

Device Problem Difficult to Remove (1528)

Patient Problem Internal Organ Perforation (1987)

Event Date 03/27/2015

Event Type  Injury  

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) 2015.According to the complainant, towards the end of the procedure, the access sheath migrated to the distal part of the right ureter which caused a small "tear." a stent was then placed in the affected part.The procedure was completed with this device.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 4697802
• MDR Text Key: 21174039
• Report Number: 3005099803-2015-01077
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 17707669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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
• Patient Outcome(s): Required Intervention