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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 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
(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 stomach during an endoscopy ligation of gastric fundus varicose veins procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were attempted to be deployed, but the bands got stuck together and would not deploy.Reportedly, the physician withdrew the device, and procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty in 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.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the stomach during an endoscopy ligation of gastric fundus varicose veins procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were attempted to be deployed, but the bands got stuck together and would not deploy.Reportedly, the physician withdrew the device, and procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty in 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 h6: problem code 2610 relates to 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 crimp was present on the trip wire and the trip wire was secured in the handle assembly slot when received.However, it was possible to observe that the tripwire was returned cut at the middle section, indicating an evidence of a sharp tool used.A visual examination of the ligator head found all seven bands present while five bands were observed to be moved out of their original positions.It was also noticed that the ligator teeth were bent.Additionally, the suture did not present any visual damage and 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.Based on the evaluation of the returned complaint device, these failures are likely due to handling and manipulation of the device 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.There was evidence that the trip wire was cut in order to remove the device from the scope.This condition is not considered as an issue of the device.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.
 
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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 Key9558148
MDR Text Key189899695
Report Number3005099803-2019-06428
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 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/12/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0024259355
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Date Manufacturer Received01/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age41 YR
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