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

Model Number M0062502220

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a navigator hd ureteral access sheath was received in the facility on (b)(6) 2015.According to the complainant, the tip of the navigator hd ureteral access sheath was found to be missing inside the sealed package.There was no visible damage noted on the package and the device was not used in a procedure.

Manufacturer Narrative

Visual examination of the returned navigator hd access sheath revealed that the device was properly sealed inside the pouch.The dilator and sheath were separated by the spacer with the hubs not locked together and the dilator tip retracted inside the sheath.During evaluation, the spacer was removed and the hubs were locked together.The dilator tip was then extended out of the sheath tip and was properly formed without any issues.The condition of the returned 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 ureteral access sheath was received in the facility on (b)(6) 2015.According to the complainant, the tip of the navigator hd ureteral access sheath was found to be missing inside the sealed package.There was no visible damage noted on the package and the device was not used in a procedure.

• 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: 5094642
• MDR Text Key: 26428010
• Report Number: 3005099803-2015-02710
• 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: Health Professional
• Type of Report: Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 18153758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2015
• 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