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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2020
Event Type  Injury  
Manufacturer Narrative
Patient weight - (b)(6) kg.(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 varicose vein ligation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was detached into two pieces.Reportedly, the whole device was removed from the patient, and the procedure was completed with another speedband superview super 7 device.There was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient's 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 an esophageal varicose vein ligation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was detached into two pieces.Reportedly, the whole device was removed from the patient, and the procedure was completed with another speedband superview super 7 device.There was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on (b)(6) 2020*** it was reported that the ligator head was detached into pieces.Reportedly, the ligator head was removed from the patient without any intervention.
 
Manufacturer Narrative
Block a4: patient weight - 74.5 kg block h6: device code 2907 for the reportable issue of ligator housing detached.Block h10: 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.Additional information: b1, b5, d10, h1, h3, h6.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophageal varicose vein ligation procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the device was detached into two pieces.Reportedly, the whole device was removed from the patient, and the procedure was completed with another speedband superview super 7 device.There was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on (b)(6), 2020*** it was reported that the ligator head was detached into two pieces.Reportedly, the ligator head was removed from the patient without any intervention.
 
Manufacturer Narrative
Block a4: patient weight - 74.5 kg block h6: device code 2907 for the reportable issue of ligator housing detached.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 secured in the handle assembly slot.The ligator head had three bands present which were moved out of their original positions.It was also noticed that some of the ligator teeth were bent.Additionally, it was observed that the suture was likely cut by a sharp tool and remained attached to the tripwire distal loop.It was noted that there were four knots on the suture.The suture hole showed a stress mark.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.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.
 
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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 Key9706181
MDR Text Key190366075
Report Number3005099803-2020-00436
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,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0024178442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2020
Date Manufacturer Received03/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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