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 05/06/2015

Event Type  malfunction  

Event Description

Note: this manufacturer report pertains to one of three devices used in the same procedure.Please refer to manufacturer report #3005099803-2015-01438, manufacturer report #3005099803-2015-01439 and manufacturer report #3005099803-2015-01440 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2015 that three speedband superview super 7 devices were used in the esophagus during a banding procedure performed on (b)(6) 2015.Reportedly, there was some difficulty when attaching the ligating units to the scope.According to the complainant, during the procedure, the physician tested the first speedband device (mfr.Report #3005099803-2015-01438) by deploying the first band outside the patient.The first band was able to deploy outside the patient successfully.The second band successfully deployed inside the patient; however, when the user tried to release the third band it would not deploy.The same issue occurred with the second speedband device (mfr.Report #3005099803-2015-01439).A third speedband device (mfr.Report #3005099803-2015-01440) was used.The third device was tested outside the patient by deploying the first band, which was able to deploy successfully.The second band was deployed successfully inside the patient; however, the third band misfired inside the patient.The physician removed the misfired band and the fourth band deployed successfully to complete the procedure.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 okay.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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: 4787972
• MDR Text Key: 5816279
• Report Number: 3005099803-2015-01440
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 17664548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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