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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 Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(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 an esophagus vein ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device and scope was inserted and attached into the tissue; however, the handle was unable to work.Reportedly, the physician could not find the location of the lesion and the patient had emergent bleeding.The procedure was completed with another speedband superview super 7 device.Additionally, it was noted that there was no difficulty in 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 an esophagus vein ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device and scope was inserted and attached into the tissue; however, the handle was unable to work.Reportedly, the physician could not find the location of the lesion and the patient had emergent bleeding.The procedure was completed with another speedband superview super 7 device.Additionally, it was noted that there was no difficulty in 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
Physician's phone number, (b)(6).Problem code 1069 for the reportable issue of handle broken/won't turn.Investigation results received the handle assembly of the super 7 with the ligator head, irrigation catheter and the velcro strap for analysis.A visual examination of the ligator head found all bands present with some bands moved out of their position and one band was caught under the other bands.It was noticed that the ligator head teeth were bent.The trip wire was partially rolled in the handle assembly and was secured in the handle assembly slot when received.It was also noted that the suture was cut; one section was attached to the trip wire loop, and the other section was attached to the ligator head in which likely to separate the device from the scope.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No issue was noted to the handle assembly, irrigation catheter and the velcro strap.Based on the evaluation of the returned device, the device showed neither evidence of the alleged issue nor any defect which could have contributed to the complaint.Therefore, it was concluded that the investigation conclusion code of this event is "no problem detected" since the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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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 Key8301520
MDR Text Key134883802
Report Number3005099803-2019-00420
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 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/12/2019
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0021848855
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2019
Date Manufacturer Received02/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age42 YR
Patient Weight52
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