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

Model Number M00542253

Device Problems Component Missing (2306); Misfire (2532)

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 h6: imdrf device code a050502 captures the reportable event of bands misfire.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during a variceal banding procedure.The exact procedure date was unknown.During the procedure, the bands were fired inadvertently somewhere in the esophagus.Additionally, it was also noticed that the device only had five bands instead of seven.The procedure was completed with another speedband superview super 7.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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16924382
• MDR Text Key: 315446987
• Report Number: 3005099803-2023-02457
• 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: Other
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2024
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0031049182
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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