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

Model Number M00542253

Device Problems Activation, Positioning or Separation Problem (2906); Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/05/2014

Event Type  Injury  

Event Description

Note: this is one of two reports related to two devices used during the same procedure.Please refer to mfr.Report # 3005099803-2014-01962 and mfr.Report # 3005099803-2014-02017 for the associated device information.It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) with esophageal variceal band ligation and injection sclerotherapy procedure performed on (b)(6), 2014.Reportedly, the patient was experiencing hematemesis, had a history of alcoholic cirrhosis and portal hypertension with bleeding varices, and a previous esophageal banding procedure in (b)(6) 2013.The patient had been on propranolol therapy prior to the procedure.According to the complainant, during the procedure, the first speedband device was placed in the esophagus, the varix was aspirated into the ligator housing but the band failed to deploy.The varix was released without incident and the device was withdrawn.A second speedband device was used and successfully deployed 2 bands; however, the third band failed to deploy.As the varix was released, it started to bleed.The endoscope and device were withdrawn and the patient was intubated to aspirate the blood.The patient was intubated successfully.Sclerotherapy injection of ethanolamine was given to resolve the bleeding; however the bleeding did not completely stop.Another speedband device was used to completed the procedure and after the additional bands were placed, it did appear that the bleeding had fully stopped.According to the physician, the patient was given 4 units of packed red blood cells, 2 units of fresh frozen plasma and 1 unit of platelets due to the severity of the bleed.No other complications resulted from this event.The patient remained intubated following the procedure and was discharged on (b)(6), 2014 to a long term care facility.

Manufacturer Narrative

(b)(4).The complainant indicated that the device was 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3808070
• MDR Text Key: 4367752
• Report Number: 3005099803-2014-01962
• 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: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2014
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 16491889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2013
• 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): Required Intervention
• Patient Age: 41 YR