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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 Premature Activation (1484); Component Missing (2306); Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/27/2019
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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, it was noted that there were only five bands present on the ligator cap.Reportedly, the physician adjusted the spool; however, two bands deployed together.Then, the device was attempted to be deployed, but elastic bands would not release.The procedure was completed with another speedband superview super 7 device.Additionally, 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 a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 2610 captures the reportable issue of bands failed to deploy.Problem code 1484 captures the reportable issue of bands prematurely deployed.Block h10: investigation results the returned speedband superview super 7 and the ligator head were analyzed.A visual evaluation noted that the tripwire was completely removed out of the handle and was attached to the ligator head.It was possible to observe that there were three bands present on the ligator head, and attached in their original positions; however, four knots were found on the suture, indicating that the rest of the bands were successfully deployed.It was also noticed that the ligator teeth did not present any visual damage.No issues were observed on the suture hole and the handle assembly did not present any visible damage.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No other issues with the device were noted.The reported event was not confirmed.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.
 
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, it was noted that there were only five bands present on the ligator cap.Reportedly, the physician adjusted the spool; however, two bands deployed together.Then, the device was attempted to be deployed, but elastic bands would not release.The procedure was completed with another speedband superview super 7 device.Additionally, 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.
 
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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 Key9617432
MDR Text Key189914518
Report Number3005099803-2020-00079
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 03/06/2020
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 Date07/29/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0024185674
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Initial Date Manufacturer Received 12/27/2019
Initial Date FDA Received01/22/2020
Supplement Dates Manufacturer Received02/12/2020
Supplement Dates FDA Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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