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

Model Number M00542250

Device Problems Premature Activation (1484); Misfire (2532); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Manufacturer report #3005099803-2014-03636 pertains to the first speedband superview super 7 device and manufacturer report #3005099803-2014-03637 pertains to the second speedband superview super 7 device.It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) with banding procedure performed on (b)(6) 2014.According to the complainant, during the procedure, when the physician rotated the handle to deploy the bands of the first device they would either deploy in advance or deploy late.The same issue occurred with the second device.The procedure was completed using a third speedband superview super 7 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.Additional information received on (b)(4) 2014.The complainant clarified that the bands prematurely deployed.Reportedly, the bands did not deploy on the click.

Manufacturer Narrative

Reported issue of bands prematurely deployed.The device was not returned; therefore, a technical analysis could not be performed.Given the event description, there isn't enough information to determine a probable root cause.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Manufacturer report #3005099803-2014-03636 pertains to the first speedband superview super 7 device and manufacturer report #3005099803-2014-03637 pertains to the second speedband superview super 7 device.It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) with banding procedure performed on (b)(6) 2014.According to the complainant, during the procedure, when the physician rotated the handle to deploy the bands of the first device they would either deploy in advance or deploy late.The same issue occurred with the second device.The procedure was completed using a third speedband superview super 7 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.Despite numerous attempts 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.

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Reported issue of 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: 4242781
• MDR Text Key: 5085278
• Report Number: 3005099803-2014-03637
• 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,Followup
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542250
• Device Catalogue Number: 4225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 67