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

Model Number M00542251

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906); Misassembly by Users (3133)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the physicians' name are dr.(b)(6) and dr.(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the varices during a procedure performed on (b)(6) 2021.According to the complainant, the handle was turned; however, there was no audible click heard.It was also noted that the band would deploy, but the handle was not being turned.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block e1: it was reported that the physicians' name are drs.(b)(6).Block h6: medical device problem code a150103 captures the reportable issue of bands prematurely deployed.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Additional information: block b5, d7 (sud reprocessed and reused), h6 ( patient codes and device codes) and h8.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the varices during a procedure performed on (b)(6) 2021.According to the complainant, the handle was turned; however, there was no audible click heard.It was also noted that the band would deploy, but the handle was not being turned.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.The speedband superview super 7 device was used in the esophagus during an endoscopy banding procedure.Reportedly, the physician take up the slack by winding the wheel rather than pulling the proximal end of trip wire on the handle unit.The procedure was completed with another speedband superview super 7 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
• MDR Report Key: 11276576
• MDR Text Key: 230218109
• Report Number: 3005099803-2021-00298
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2021
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0026459892
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1