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

Model Number M00542250

Device Problems Failure to Fire (2610); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used during a procedure performed on (b)(6) 2021.During the procedure, the device was tested and attempted to be deployed; however, the device did not work correctly as the bands were not able to be released.It was observed that the device had the bands in the opposite way, not allowing the deployment process.The procedure was completed with another speedband superview super 7 device.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.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used during a procedure performed on (b)(6), 2021.During the procedure, the device was tested and attempted to be deployed; however, the device did not work correctly as the bands were not able to be released.It was observed that the device had the bands in the opposite way, not allowing the deployment process.The procedure was completed with another speedband superview super 7 device.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: medical device problem code a050501 for the reportable issue of bands failed to deployed.Block h10: investigation results the returned speedband superview super 7 was analyzed.A visual evaluation noted that the handle assembly and ligator head were returned with the device.Tripwire was partially rolled and was not secured on the handle assembly, and the slack was not taken up correctly.It was noted that the ligator head was returned with four bands present and were moved out of their original positions.Additionally, three of the bands were broken and overlapped with the attached bands.The ligator teeth were bent.The suture was intact and attached to the distal tripwire loop.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard, and indents were felt.No visible issue was noted with the handle assembly.No other issues with the device were noted.The reported event of failure to deploy bands was confirmed.The reported event of device misassembled during manufacturing or shipping was not confirmed.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label.The visual assessment identified that the trip wire was not secured in the handle slot, nor did the handle have evidence that the trip wire was previously secured.Additionally, the slack was not removed properly.Not following these steps can cause the tripwire to slip through the handle assembly and contribute to an inaccurate deployment of the bands and more tension on the device.The extra tension on the device can lead to damage to the ligator head teeth and cause the bands to break.Taking all available information into consideration, the most probable root cause of this event is failure to follow instructions.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 12052779
• MDR Text Key: 260697679
• Report Number: 3005099803-2021-02876
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201953
• UDI-Public: 08714729201953
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2022
• Device Model Number: M00542250
• Device Catalogue Number: 4225
• Device Lot Number: 0026612681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1