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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 10/20/2019
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 during an esophageal variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band was attempted to be deployed; however, the band was entangled with the other band causing the band 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 condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
(b)(4).Investigation results: only the ligator head was returned for analysis.The handle was not returned with the device.A visual examination of the returned component found four bands present which were moved out of their original positions.It was also noticed that the ligator head teeth were bent.The suture was found cut; one portion was attached to the ligator head and the other portion was not returned.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 which could have contributed to the reported issues.Also, it is likely that the suture was cut to remove the device from the scope and 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.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophageal variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band was attempted to be deployed; however, the band was entangled with the other band causing the band 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 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 Key9305711
MDR Text Key189702765
Report Number3005099803-2019-05496
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/06/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0023751527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Initial Date Manufacturer Received 10/21/2019
Initial Date FDA Received11/11/2019
Supplement Dates Manufacturer Received11/26/2019
Supplement Dates FDA Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
Patient Weight55
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