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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 Use of Device Problem (1670); Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2019
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 stomach during an endoscopic variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands would not release.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty setting up the device.It was also noted that the technician removed the shrink wrap from the ligator head prior to handing to the physician, instead of removing it after setting up the device as instructed in the directions for use.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 in the stomach during an endoscopic variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands would not release.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty setting up the device.It was also noted that the technician removed the shrink wrap from the ligator head prior to handing to the physician, instead of removing it after setting up the device as instructed in the directions for use.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: a speedband superview super 7 was returned with the ligator head for analysis.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.A visual examination of the ligator head found seven bands present which were moved out of their original positions.It was also noticed that the ligator teeth were bent.The suture was cut; a section of the suture was attached to the trip wire loop and the other section was attached to the ligator head.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.Additionally, the ligator head was not in its plastic shrink wrap when received.The returned device review showed that the device was not used per the directions for use (dfu)/product label.Based on the evaluation of the returned device, the physician removed the ligator shrink wrap earlier in the setup process and it is the step number 10 in the dfu.This failure is likely related to misuse of the device without any design or manufacturing issue.Therefore, the most probable root cause is failure to follow 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; as the ligator shrink wrap on the device was removed prior to the setup process.
 
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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 Key8847016
MDR Text Key153126923
Report Number3005099803-2019-03895
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 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/15/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0023353168
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2019
Date Manufacturer Received08/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age70 YR
Patient Weight56
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