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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 Use of Device Problem (1670); Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2019
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 stomach during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands would not deploy.There was no difficulty in setting up the device.The procedure was completed with another speedband superview super 7 device.Additionally, the ligator shrink wrap on the device was removed prior to the setup process.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 endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands would not deploy.There was no difficulty in setting up the device.The procedure was completed with another speedband superview super 7 device.Additionally, the ligator shrink wrap on the device was removed prior to the setup process.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 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 crimp was present on the trip wire.A visual examination of the ligator head found one band present which was moved out of its original position.It was noticed that the ligator head teeth were bent.The trip wire was secured in the handle assembly slot when received.The suture was cut, attached to the trip wire loop and the other section was attached to the ligator head.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.Additionally, the ligator head was not in its plastic wrap when received.The returned device review showed that the device was not used per the directions for use (dfu)/product label.Based on the evaluation of the returned device, the physician removed the ligator shrink wrap earlier in the setup process and it is the step number 10 in the dfu.This failure is likely related to misuse of the device without any design or manufacturing issue.Therefore, the most probable root cause is failure to follow instructions.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 not used per the directions for use (dfu) / product label; as the ligator shrink wrap on the device was removed prior to the setup process.
 
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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 Key8717153
MDR Text Key148951058
Report Number3005099803-2019-03124
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 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/07/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0023308972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Date Manufacturer Received05/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
Patient Weight82
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