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 06/18/2019

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 stomach during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the suture cut off and the bands failed to deploy.The procedure was completed with another seedband superview super 7 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 stable.

Manufacturer Narrative

Problem code 2610 for the reportable issue of bands failed to deploy.Problem code 2907 for the reportable issue of suture detached.Investigation results received one speedband superview super 7 with the ligator head for analysis.It was noticed that the crimp was present on the trip wire and the trip wire was secured in the handle assembly slot when received.A visual examination of the ligator head found five bands present which were moved out of their original positions and one band was caught under the other bands.It was also noticed that the ligator teeth were bent.The suture was broken; was attached to the ligator head, and the other portion was attached to the trip wire loop.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No visible issue was noted with the handle assembly.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 impacted the bands deployment activity, moving bands without being properly deployed and contributing to the reported issues.Also, the suture can tangle with the bands which can result in difficulty to rotate the handle and continued attempts to deploy the bands can result in suture breakage.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.Correction: e1 (initial reporter zip/post code).

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the stomach during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the suture cut off and the bands failed to deploy.The procedure was completed with another seedband superview super 7 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 stable.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the stomach during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the suture cut off and the bands failed to deploy.The procedure was completed with another seedband superview super 7 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 stable.

Manufacturer Narrative

Block h6: problem code 2610 for the reportable issue of bands failed to deploy.Problem code 2907 for the reportable issue of suture detached.Block h10: investigation results received one speedband superview super 7 with the ligator head for analysis.It was noticed that the crimp was present on the trip wire and the trip wire was secured in the handle assembly slot when received.A visual examination of the ligator head found five bands present which were moved out of their original positions and one band was caught under the other bands.It was also noticed that the ligator teeth were bent.The suture was broken; was attached to the ligator head, and the other portion was attached to the trip wire loop.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No visible issue was noted with the handle assembly.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 impacted the bands deployment activity, moving bands without being properly deployed and contributing to the reported issues.Also, the suture can tangle with the bands which can result in difficulty to rotate the handle and continued attempts to deploy the bands can result in suture breakage.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.

• 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: 8798214
• MDR Text Key: 151299796
• Report Number: 3005099803-2019-03618
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0022831035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 70