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

Model Number M0062502260

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a navigator hd access sheath was used during ureteroscopy procedure performed on (b)(6) 2014.According to the complainant, during the procedure the tip of the navigator access sheath had detached inside the patient and was successfully retrieved.The procedure was completed with this device.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 fine.

Manufacturer Narrative

Visual examination of the returned navigator hd access sheath revealed that the sheath was bent in several locations along the working length.The distal tip of the dilator had not been detached, but it appeared slightly bent.Also, two small fragments of black-colored material were noted along with the returned device.The condition of the returned incident device showed no evidence of the alleged issue which could have contributed to the event.Based on all gathered information, the most probable root cause is: not confirmed.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a navigator hd access sheath was used during ureteroscopy procedure performed on (b)(6) 2014.According to the complainant, during the procedure the tip of the navigator access sheath had detached inside the patient and was successfully retrieved.The procedure was completed with this device.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 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: 4308445
• MDR Text Key: 5271019
• Report Number: 3005099803-2014-03893
• 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,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/22/2016
• Device Model Number: M0062502260
• Device Catalogue Number: 250-226
• Device Lot Number: 17305948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2014
• 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