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 09/12/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2014 that a speedband superview super7 device was used to treat an internal hemorrhoid in the rectum during a banding procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the physician did not feel any resistance turning the handle when attempting to deploy the bands.An audible click was heard; however, no band deployed.When the physician removed the suction away from the hemorrhoid, the bands misfired and fell off the device.The procedure was completed with another speedband superview super7 device.There were no patient complications reported as a result of this event.The patients' condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

(b)(4) bands misfired.The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4147088
• MDR Text Key: 19804973
• Report Number: 3005099803-2014-03341
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020824
• 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: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2015
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 16999755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2014
• 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