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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 M00542251
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2018
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.(b)(4).
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a varicose vein ligation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, two bands deployed at the same time.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 ligator head for analysis.It was noticed that the crimp was present on the trip wire.A visual examination of the ligator head found six bands present.It was noticed that the ligator head teeth were bent.The suture was broken and attached to the ligator head, likely it was broken to separate the device from the scope.The trip wire was partially rolled in the handle and was secured in the handle assembly when received.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 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, which could have contributed with the reported issues.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.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a varicose vein ligation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, two bands deployed at the same time.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.
 
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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 Key7679304
MDR Text Key114011702
Report Number3005099803-2018-02167
Device Sequence Number1
Product Code FHN
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 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/21/2018
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number20915668
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Date Manufacturer Received07/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
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