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, ESOPHAGEAL
  • 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, ESOPHAGEAL Back to Search Results
Model Number M00542253
Device Problems Failure to Fire (2610); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
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 a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle was rotated; however, no audible click was heard and the band would not fire.The procedure was completed with another speedband superview super 7 device.It was noted that there was no difficulty experienced upon setting up the 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.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle was rotated; however, no audible click was heard and the band would not fire.The procedure was completed with another speedband superview super 7 device.It was noted that there was no difficulty experienced upon setting up the 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: device code 2610 captures the reportable issue of bands failed to deploy.Block h10: investigation results the returned speedband superview super 7 was analyzed, and a visual evaluation noted that the handle assembly and ligator head were returned with the device.A crimp was present on the trip wire.The trip wire was partially rolled in the handle assembly and was secured in the handle slot when received.It was possible to observe that the trip wire was bent in several locations at the proximal section.The suture was intact and attached to the distal trip wire loop.It was noted that the ligator head had five bands attached, but all of the bands were moved out of their original positions, while the white band and one blue band were broken and they were caught under the other bands.Additionally, the suture hole was slightly torn and some of the ligator head teeth were damaged.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 on the handle assembly and no other issues with the device were noted.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 which could have contributed with the reported issues.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPEEDBAND SUPERVIEW SUPER 7
Type of Device
LIGATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9889464
MDR Text Key191294934
Report Number3005099803-2020-01349
Device Sequence Number1
Product Code MND
UDI-Device Identifier08714729201953
UDI-Public08714729201953
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,health
Type of Report Initial,Followup
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number0024521032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Date Manufacturer Received05/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-