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

Model Number M00542251

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

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

Event Date 01/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem 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 speedband superview super 7 device was used in the esophagus during a band ligation procedure performed on (b)(6) 2022.During the procedure, the band was attempted to be deployed but it was noticed that the trip wire did not pull the lowest band as intended, instead it pulled at the upper band so the bands could not be deployed.Additionally, it was observed that the suture was mounted to the bands in a wrong way.The procedure was completed with another speedband superview super 7 device.There was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device code a050501 captures the reportable event of bands unable to deploy.Block h10: investigation results: one speedband superview super 7 was returned for analysis (handle assembly and ligator head).The returned speedband superview super 7 was analyzed, and a visual evaluation noted that the ligator head was returned with all seven bands attached which some of the bands were moved from their original positions and overlapped.The trip wire was returned cut.It was also observed that the trip wire was not secured in the handle slot and the slack was not taken up correctly.The suture thread was in good condition with seven knots.A media inspection was done on the video and the two photos provided by the customer and it was observed that the bands were overlapped, the trip wire was not secured, and the slack was not taken up correctly.Microscopic examination was performed and it was found that the ligator head teeth were damaged (bent).The suture hole was in good condition.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard, and indents were felt.No other problems with the device were noted.The reported event was confirmed.The bands moved from their original positions and overlapped indicating a deployment problem possibly related to the damages observed on the ligator head teeth.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 and the slack was not taken up correctly.Failure to follow this steps could have caused the trip wire to slip through the handle assembly during deployment and contribute to an inaccurate deployment of the bands.Taking all available information into consideration, the most probable root cause of this event is failure to follow instructions.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that speedband superview super 7 device was used in the esophagus during a band ligation procedure performed on (b)(6) 2022.During the procedure, the band was attempted to be deployed but it was noticed that the trip wire did not pull the lowest band as intended, instead it pulled at the upper band so the bands could not be deployed.Additionally, it was observed that the trip wire was mounted to the band in a wrong way.The procedure was completed with another speedband superview super 7 device.It was also noted that there was no difficulty experienced upon setting up the 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
• 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: 13534927
• MDR Text Key: 288374119
• Report Number: 3005099803-2022-00527
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0027780692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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