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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 Problem Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2019
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 gastroesophageal varices ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were sticking together causing the bands to fail 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.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
(b)(4).Investigation results: received one speedband superview super 7 with the ligator head for analysis.It was noticed that trip wire was partially rolled and secured in the handle assembly slot when received.A visual examination of the ligator head found six bands present which were moved out of their original positions, while some bands were caught under other bands.It was also noticed that the ligator teeth were bent.It was also possible to observe that the suture was broken, likely to separate the device from the scope.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 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 deployed, and contributing to the reported issues.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.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a gastroesophageal varices ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were sticking together causing the bands to fail 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.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 CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9306296
MDR Text Key189701445
Report Number3005099803-2019-05513
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 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/10/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0023465295
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Date Manufacturer Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
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