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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 M00542253
Device Problems Positioning Failure (1158); Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.(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 variceal banding procedure performed on an unknown date.According to the complainant, during the procedure, the bands would not deploy.Reportedly, the device was then removed and the procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty experienced setting up the 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 fine.
 
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.(b)(4).Investigation results: a speedband superview super 7 was returned with 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 one band present which was moved out of its position.It was noticed that the ligator teeth were bent.The suture was noted to be intact and attached to the trip wire loop.The tripwire was secured in the handle assembly.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.  based on the evaluation of the returned ligator head, 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 which could have contributed with 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.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an variceal banding procedure performed on an unknown date.According to the complainant, during the procedure, the bands would not deploy.Reportedly, the device was then removed and the procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty experienced setting up the 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 fine.
 
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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 Key8271258
MDR Text Key133934883
Report Number3005099803-2019-00105
Device Sequence Number1
Product Code FHN
UDI-Device Identifier08714729504832
UDI-Public08714729504832
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,health
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/12/2019
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number0022644963
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2019
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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