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

Model Number M00542253

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Premature Activation (1484); Misfire (2532); Failure to Fire (2610); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the sales representative.The healthcare facility is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the handle was hard to rotate without a clicking sound.The bands did not deploy correctly off of the ligator.The ligator bands were intentionally deployed but were fired in an unintentional location.The physician also had trouble getting the bands to deploy and there was a time wherein multiple bands were deployed.The procedure was completed with another speedband superview super 7.It was noted that there was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.

• 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: 15920995
• MDR Text Key: 307910551
• Report Number: 3005099803-2022-07190
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729504832
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0029178475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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