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

Model Number M00542251

Device Problems Positioning Failure (1158); Misfire (2532); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2015

Event Type  Injury  

Event Description

Note: this report pertains to one of three devices used during the same procedure.Manufacturer report # 3005099803-2015-02149 pertains to the first speedband superview super 7 device, manufacturer report # 3005099803-2015-02150 pertains to the second speedband superview super 7 device and manufacturer report # 3005099803-2015-02151 pertains to the third speedband superview super 7 device.It was reported to boston scientific corporation on july 6, 2015 that three speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) and banding procedure performed on (b)(6) 2015.Patient was treated for enlarged esophageal varices with no active bleeding.According to the complainant, during the procedure, the user set up the device and then suctioned the varix using the first speedband device (manufacturer report # 3005099803-2015-02149).The handle was turned and a ¿click¿ was heard; however, the band did not move off the ligating cap onto the varix.Another band was then deployed, it was able to successfully deploy off the ligating cap but was unable to affix onto the varix.The user then tried to deploy another band and this time, the band was able to deploy successfully.Deployed another band again but was unsuccessful and the physician removed the first speedband device.A second speedband device (manufacturer report # 3005099803-2015-02150) was used and two bands were able to successfully deploy but some of the bands did not move off the kit when being deployed.The user then changed to a third speedband device (manufacturer report # 3005099803-2015-02151), a couple of bands were used; however, this device was reportedly noted not to fire properly despite having a good suction of the varix.The procedure was completed with the third speedband superview super 7 device.The patient's condition at the conclusion of the procedure was reported to be stable but the physician noted some minor bleeding during the procedure.There was no active bleeding at the end of the procedure but the physician chose to admit the patient for an overnight observation.The patient was discharged on (b)(6) 2015.

Manufacturer Narrative

(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: 4954136
• MDR Text Key: 6038572
• Report Number: 3005099803-2015-02149
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 17471573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2014
• 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
• Patient Outcome(s): Hospitalization