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

Model Number M00542253

Device Problems Suction Problem (2170); Human-Device Interface Problem (2949)

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

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date, the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a22, captures the reportable event of bands fell off the varix.

Event Description

Note: this report pertains to second of two speedband superview super 7, used during the same procedure.It was reported to boston scientific corporation, that a speedband superview super 7 was used in the esophagus, during an esophagogastroduodenoscopy (egd) procedure.The exact procedure date was unknown.During the procedure, "the initial band misdeployed and obstructed the view in front of the cap".A second speedband superview super 7 was used and the bands deployed correctly.However, it would not stick to the tissue.The physician stated, the suction felt weak.It was unknown how was the procedure completed.It was noted, that there was no difficulty experienced upon setting up the devices.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 16826264
• MDR Text Key: 314128414
• Report Number: 3005099803-2023-02164
• Device Sequence Number: 1
• Product Code: MND
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• 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