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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 Positioning Failure (1158); Defective Device (2588); Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that three speedband superview super 7 devices were used in the esophagus during an esophageal variceal ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the suture wire was hidden in the ligator cap which caused difficulty setting up the device.Consequently, the bands would not deploy successfully inside the patient.The same issue occurred with the second and third speedband superview super 7 devices.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that three speedband superview super 7 devices were used in the esophagus during an esophageal variceal ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the suture wire was hidden in the ligator cap which caused difficulty setting up the device.Consequently, the bands would not deploy successfully inside the patient.The same issue occurred with the second and third speedband superview super 7 devices.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Problem code 2610 captures the reportable issue of bands failed to deploy.Problem code 2588 captures the reportable event of suture stuck inside the ligator cap.A speedband superview super 7 was returned with the ligator head for analysis.A visual examination of the ligator head found no visual defects with the handle assembly; however, the suture was noted to be incorrectly positioned inside the ligator cap.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.This failure is likely due to problems traced to manufacturing process.Therefore, the most probable root cause is manufacturing deficiency.An investigation to address this issue has been completed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.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 Key8352020
MDR Text Key136616733
Report Number3005099803-2019-00733
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 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/07/2019
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number22901439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2019
Date Manufacturer Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
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