MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPEEDBAND SUPERVIEW SUPER 7?; LIGATOR, HEMORRHOIDAL

Model Number M00542253

Device Problems Misfire (2532); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used during a therapeutic endoscopy procedure performed on (b)(6) 2014.Reportedly, the indication for the procedure was suspicion of lower esophageal varices just above the gastroesophageal junction.According to the complainant, during the procedure, the first band deployed without issue.However, the second band deployed without an audible click when the handle was rotated.The band was misfired.Another speedband device was used to complete the procedure.No patient complications resulted from this event.The patient's condition following the procedure was reported to be fine.

Manufacturer Narrative

Reported event of band misfired.A visual and functional examination of the complaint device could not be performed since the device was not returned for analysis.Given the event description and the device not being returned for analysis, there isn't enough information to determine a probable root cause.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A search of the complaint database confirmed that no other complaints exist for the specified batch.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7?
• Type of Device: LIGATOR, HEMORRHOIDAL
• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3928606
• MDR Text Key: 4664787
• Report Number: 3005099803-2014-02430
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K020824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/28/2015
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 16854221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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