MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, ESOPHAGEAL

Model Number M00542250

Device Problems Difficult or Delayed Positioning (1157); Misfire (2532)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) with variceal banding procedure performed on (b)(6) 2021.During the procedure, the bands were difficult to deploy and ultimately misfired in a wrong location which caused bleeding.It was reported that the patient was transported to an interventional radiologist and a transjugular intrahepatic portosystemic shunt (tips) procedure was performed to stop the bleeding.It was noted that there was no difficulty experienced upon setting up the speedband superview super 7 device.The patient's condition following the treatment was not reported and it unknown if the egd procedure is to be rescheduled.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12303779
• MDR Text Key: 265981158
• Report Number: 3005099803-2021-04045
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201953
• UDI-Public: 08714729201953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• 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: 07/16/2021
• 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 Outcome(s): Required Intervention