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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, HEMORRHOIDAL
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BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, HEMORRHOIDAL Back to Search Results
Model Number M00542251
Device Problems Failure to Fire (2610); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2018
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(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 an esophageal variceal ligation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the bands were stuck with the wire and the bands failed to deploy.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.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophageal variceal ligation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the bands were stuck with the wire and the bands failed to deploy.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.
 
Manufacturer Narrative
Received one speedband device with the velcro strap and the ligator head for analysis.A visual examination of the ligator head found two bands present which indicates that the bands failed to deploy during procedure.It was noticed that the ligator head teeth were bent.Further examination of the trip wire found bent in several locations and was secured in the handle assembly slot when received.The suture was cut, likely to separate the device from the scope, therefore it is not considered as an issue of the device.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.Based on the information available and the analysis performed, it was concluded that the investigation conclusion code of this event is cause traced to component failure, since expected or random component failure without any design or manufacturing issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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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 Key7955754
MDR Text Key123376334
Report Number3005099803-2018-60825
Device Sequence Number1
Product Code FHN
UDI-Device Identifier08714729201960
UDI-Public08714729201960
Combination Product (y/n)N
PMA/PMN Number
510K EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/24/2019
Device Model NumberM00542251
Device Catalogue Number54145
Device Lot Number0021651371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2018
Date Manufacturer Received10/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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