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

Model Number M00542251

Device Problems Failure to Fire (2610); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

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 lower third of the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the first band was attempted to deploy; however, the band would not released.Reportedly, the device was removed from the patient and it was discovered that the bands were loose, and tangled with the attachment string.There was no difficulty experienced when setting up the device.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 lower third of the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the first band was attempted to deploy; however, the band would not released.Reportedly, the device was removed from the patient and it was discovered that the bands were loose, and tangled with the attachment string.There was no difficulty experienced when setting up the device.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.Reportedly, the suture was not detached as it was still attached on the ligator head.

Manufacturer Narrative

(b)(4).Investigation results: only the ligator head was returned for analysis.A visual examination of the ligator head found seven bands present which were moved out of their original positions.It was also noticed that the ligator teeth were bent.The suture was found cut; one portion was attached to the ligator head and the other portion was not returned.No other issue was noted on the device.Based on the evaluation of the returned ligator head, 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 impacted the bands deployment activity which could have contributed with the reported issues.Also, it is likely that the suture was cut to separate the device from the scope and this condition is not considered as an issue of the device.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.

Manufacturer Narrative

Block h6: problem code 2610 captures the reportable issue of bands failed to deploy.Block h10: 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 lower third of the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the first band was attempted to deploy; however, the band would not released.Reportedly, the device was removed from the patient and it was discovered that the bands were loose, and tangled with the attachment string.There was no difficulty experienced when setting up the device.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.Additional information received on august 09, 2019.Reportedly, the suture was not detached as it was still attached on the ligator head.

• 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: 8879011
• MDR Text Key: 153840442
• Report Number: 3005099803-2019-04032
• 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,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2020
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0023615811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1