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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 Problem Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and 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 an unknown date.According to the complainant, during the procedure, the device failed to deploy elastic bands.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty experienced upon 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 stable.
 
Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Block h6: problem code 2610 for the reportable issue of bands failed to deploy.Block h10: investigation results received one speedband superview super 7 with the ligator head for analysis.It was noticed that the trip wire was completely rolled in the handle assembly slot when received.A visual examination of the ligator head found all seven bands present, which were moved out of their original positions.It was also noticed that the ligator teeth were bent.Additionally, the suture was observed to be broken with one section was attached to the ligator head, while the other section was attached to the trip wire loop.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.There was evidence that the suture was broken in order to separate the device from the scope.This condition is not considered as an issue of the device.Based on the evaluation of the returned complaint 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 and could have contributed 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.
 
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 an unknown date.According to the complainant, during the procedure, the device failed to deploy elastic bands.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty experienced upon 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 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 Key9476859
MDR Text Key189780401
Report Number3005099803-2019-06085
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 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/11/2020
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number0023636016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Initial Date Manufacturer Received 11/21/2019
Initial Date FDA Received12/16/2019
Supplement Dates Manufacturer Received01/10/2020
Supplement Dates FDA Received02/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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