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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPEEDBAND SUPERVIEW SUPER 7¿; LIGATOR, HEMORRHOIDAL
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BOSTON SCIENTIFIC - SPENCER SPEEDBAND SUPERVIEW SUPER 7¿; LIGATOR, HEMORRHOIDAL Back to Search Results
Model Number M00542250
Device Problems Break (1069); Positioning Failure (1158)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2018
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 a band ligation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the third band was attempted to be deployed; however, the band failed to deploy.Reportedly, the handle got stuck and the tripwire was broken.There was no difficulty in 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.The patient's 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 esophagus during a band ligation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the third band was attempted to be deployed; however, the band failed to deploy.Reportedly, the handle got stuck and the tripwire was broken.There was no difficulty in 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.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Received one speedband device with the velcro strap and the ligator head for analysis.It was noticed that the crimp was present on the trip wire.A visual examination of the ligator head found five bands present.It was noticed that the ligator head teeth were bent.The trip wire was bent in several locations and was broken with an evidence of bending and torsion.The suture was intact and attached to the trip wire loop and ligator head.There was evidence that the trip wire was secured in the handle assembly slot.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No issue was noted with the handle assembly and the velcro strap.Based on the evaluation of the returned 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 trip wire was bent and the ligator head teeth were damaged due to handling and manipulation of the device during 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 deployed, and contributing to the reported issues.Additionally, if the trip wire presents slack, this can cause that it gets stuck in the handle spool and excessive force applied during the handle rotation can lead to break the trip wire.Based on the information available and the analysis performed, the most probable cause for the complaint event is operational context, probably due to anatomical/procedural factors encountered during the procedure, performance was limited.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.
 
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Brand Name
SPEEDBAND SUPERVIEW SUPER 7¿
Type of Device
LIGATOR, HEMORRHOIDAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
MDR Report Key7761437
MDR Text Key116373545
Report Number3005099803-2018-02512
Device Sequence Number1
Product Code FHN
UDI-Device Identifier08714729201953
UDI-Public08714729201953
Combination Product (y/n)N
PMA/PMN Number
K020824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/14/2018
Device Model NumberM00542250
Device Catalogue Number4225
Device Lot Number21385161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2018
Date Manufacturer Received08/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
Patient Weight60
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