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

Model Number M00542251

Device Problems Break (1069); Positioning Failure (1158); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020 as the event date is unknown.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Health professional was approximated to yes as the initial reporter's occupation is unknown, but the event was reported to have occurred at a health care facility.(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a banding of esophageal varices procedure performed on an unknown date.According to the complainant, during the procedure, the first band was successfully deployed around the varices; however, when the second band was tried to shoot, it would not deploy.Reportedly, the gastroscope together with the device were removed from the patient, and it was found that the elastic bands were entangled together with the suture.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.The patient condition at the conclusion of the procedure was reported to be okay and stable.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a banding of esophageal varices procedure performed on an unknown date.According to the complainant, during the procedure, the first band was successfully deployed around the varices; however, when the second band was tried to shoot, it would not deploy.Reportedly, the gastroscope together with the device were removed from the patient, and it was found that the elastic bands were entangled together with the suture.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.The patient condition at the conclusion of the procedure was reported to be okay and stable.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2020 as the event date is unknown.Block e2: health professional was approximated to yes as the initial reporter's occupation is unknown, but the event was reported to have occurred at a health care facility.Block h6: device code 2610 captures the reportable event of bands failed to deploy.Device code 1069 captures the reportable event of suture broken.Block h10: investigation results: the returned speedband superview super 7 device was analyzed, and a visual evaluation noted that the tripwire was partially rolled and there was evidence that it was secured in the handle assembly when received; however, it was kinked in several locations.Further analysis noted under high magnification that the evidence of tripwire cut by an unknown tool was likely to remove the device from the scope.This condition is not considered as an issue of the device.The suture was intact and it was attached to the trip wire loop.Additionally, the ligator head had six bands attached to it while some bands were moved out of their positions and some were caught under the other bands, confirming the reported deployment failure.It was also noticed that some ligator head teeth were damaged, indicating that the component was submitted to a tension.The suture hole was in good condition and no damages were observed.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No other issues with the device were noted.The reported event was confirmed.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.

• 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: 10001567
• MDR Text Key: 191673478
• Report Number: 3005099803-2020-01790
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0025176093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1