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

Model Number M00542253

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reported issue of bands failed to deploy.Reported issue of bands deployed prematurely.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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016 that a speedband superview super 7 device was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the bands failed to deploy.After another attempt to deploy the bands, multiple bands deployed all at once.The patient's condition at the conclusion of the procedure was reported as "not harmed." boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 5573834
• MDR Text Key: 42541569
• Report Number: 3005099803-2016-00988
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 18742437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1