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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2019
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 in the esophagus during an esophagogastroduodenoscopy (egd) with variceal banding procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the elastic bands failed to deploy and was found to be overlapping on each other.There was no difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7.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: the returned speedband superview super 7 device and the ligator head were analyzed.A visual evaluation noted that the crimp was present on the trip wire and the trip wire was completely rolled around the spool of the handle.It was noted that the trip wire was not secured on the handle assembly slot, as there was no evidence of drag marks.The ligator head found five bands attached which were moved out of their original positions and one band was returned detached from the ligator head.It was also noticed that some of the ligator teeth were bent.Additionally, the suture was attached to the distal loop of the tripwire; however, it was not connected to the ligator head.There were seven knots found on the suture and no damages were observed.The suture hole was in good condition and no defects found.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.No other issues with the device were noted.The reported event was confirmed.Based on the condition and evaluation of the returned device, the most probable root cause is failure to follow instructions since the problem was traced to the user not following the manufacturer instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label that the trip wire was not properly secured in the handle slot, as indicated in the step 8.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) with variceal banding procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the elastic bands failed to deploy and was found to be overlapping on each other.There was no difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7.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 Key9617862
MDR Text Key190608765
Report Number3005099803-2020-00120
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,health
Type of Report Initial,Followup
Report Date 03/24/2020
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 Date11/07/2020
Device Model NumberM00542253
Device Catalogue Number4225-40
Device Lot Number0024739121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2020
Initial Date Manufacturer Received 12/31/2019
Initial Date FDA Received01/22/2020
Supplement Dates Manufacturer Received02/28/2020
Supplement Dates FDA Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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