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

Model Number M00542253

Device Problems Use of Device Problem (1670); Failure to Fire (2610); Activation, Positioning or Separation Problem (2906)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation, that a speedband superview super 7 was used in the distal esophagus, during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, the handle was rotated fully.However, the bands could not be deployed.It was reported, that there was an "enhanced tactile resistance".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.Note: it was reported, that the ligator shrink wrap was removed at the "beginning of setup".However, per the instructions for use (ifu), "removal of the ligator shrink wrap is done at the end of the setup".

Manufacturer Narrative

Block h6: imdrf device code a050501, captures the reportable event of bands unable to deploy.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16881089
• MDR Text Key: 314683632
• Report Number: 3005099803-2023-02353
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729504832
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2023
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0030760614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• 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