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

Model Number M00542251

Device Problems Positioning Failure (1158); Use of Device Problem (1670); Failure to Fire (2610); Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the first band successfully deployed, but attempts to deploy the additional bands were unsuccessful.Reportedly, the device was removed from the scope and the handle was turned to remove a band from the tip of the ligator head.It was found that the suture did separate in order to release the band; however, none of the bands were fired.It was also noted that the physician did not pull the wire to create tension, instead, the handle was turned until the tension was felt.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.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6: device code 2610 for the reportable issue of bands failed to deploy.Block h10: investigation results the returned speedband superview super 7 was analyzed, and a visual evaluation noted that the handle assembly and ligator head were returned with the device.It was also noted that the trip wire was completely rolled in the handle assembly and the crimp was present on the tripwire.However, there was no evidence that the trip wire was secured in the handle slot when received.There were six knots found in the suture and were attached to the distal loop of the trip wire.However, the last suture knot was found loose.Additionally, the ligator head had six bands attached with two bands were moved out of their original positions.It was also noted that the ligator head teeth were bent and the suture hole was found damaged.No other issues with the device were noted.The reported event was confirmed.Based on the condition and evaluation of the returned device, this failure is likely related to misuse of the device without any design or manufacturing issue.Therefore, the most probable root cause is failure to follow instructions.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 not used per the directions for use (dfu)/product label, as the trip wire was not properly secured in the handle assembly and the slack on the trip wire was not properly removed, indicated in the step 4, 7, 8, and 10.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the first band successfully deployed, but attempts to deploy the additional bands were unsuccessful.Reportedly, the device was removed from the scope and the handle was turned to remove a band from the tip of the ligator head.It was found that the suture did separate in order to release the band; however, none of the bands were fired.It was also noted that the physician did not pull the wire to create tension, instead, the handle was turned until the tension was felt.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.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 10058979
• MDR Text Key: 191737779
• Report Number: 3005099803-2020-01893
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2021
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0025402327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1