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

Model Number M00542251

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

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 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 elastic band was attempted to be deployed, but the band failed to deploy.Reportedly, the device was pulled out from the patient, and it was noted that the bands were clumped up together.The procedure was completed with another speedband superview super 7 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 in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the elastic band was attempted to be deployed, but the band failed to deploy.Reportedly, the device was pulled out from the patient, and it was noted that the bands were clumped up together.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.

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 and the ligator head were analyzed; however, the handle assembly, tripwire and suture were not returned.A visual evaluation noted that the ligator head found six bands attached which were out of their original positions and the seventh band was not returned.The suture hole was in good condition and no damages were observed.It was possible to observe that some of the ligator head teeth were bent.No other issues with the device were noted.Based on the evaluation of the returned complaint device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.It is most likely that the ligator head teeth were damaged due to handling and manipulation of the device during the procedure.Once the ligator head teeth are damaged, the suture can be detached from its position on the ligator head and this condition could have generated the bands to moved out of their original positions, impacting the bands deployment activity and could have contributed to the reported issues.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, HEMORRHOIDAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9666938
• MDR Text Key: 190000051
• Report Number: 3005099803-2020-00257
• Device Sequence Number: 1
• Product Code: FHN
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2020
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0024297227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1