Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, HEMORRHOIDAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 11/13/2019
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 during an esophageal variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band did not fire normally.There was no difficulty experienced upon 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
Block h6: problem code 2610 for the reportable issue of bands failed to deploy.Block h10: investigation results received one speedband device for analysis and the ligator head was not returned with the device.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.The suture did not represent any visual damaged and was found attached to the trip wire loop.The returned product looked in good condition without evidence of damages.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 device, no failures were found that could have reduced the performance of the device during the procedure.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.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 did not fire normally.There was no difficulty experienced upon 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9417480
MDR Text Key189763141
Report Number3005099803-2019-05920
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 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0023825988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-