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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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2019
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).According to the complainant, the suspect device 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 a speedband superview super 7 device was used in a procedure performed on an unknown date.According to the complainant, during the procedure, the band was attempted to deployed; however, when the handle was turned, the band failed to deploy.The device was removed from the patient and an overlapping of the remaining bands was noted.The procedure was completed with another device.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in a procedure performed on an unknown date.According to the complainant, during the procedure, the band was attempted to deployed; however, when the handle was turned, the band failed to deploy.The device was removed from the patient and an overlapping of the remaining bands was noted.The procedure was completed with another device.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on july 03, 2019.It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a band ligation procedure.The procedure was completed with another speedband superview super 7 device and there was no difficulty in setting up the device.There were no patient complications reported as a result of this event and 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 06/01/2019 as no event date was reported.Block h6: problem code 2610 for the reportable issue of bands failed to deploy.Conclusion code 4316 is being used in lieu of an appropriate code to capture the conclusion of device not returned.Block h10 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.Additional information: b5 (describe event).
 
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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 Key8757913
MDR Text Key150027960
Report Number3005099803-2019-03394
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,foreig
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/30/2019
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number0022589740
Was Device Available for Evaluation? No
Date Manufacturer Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
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