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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2019
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 during an esophageal varicosity procedure performed on (b)(6) 2019.According to the complainant, prior to the procedure, it was noticed that the trip wire was abnormal.The procedure was completed with another speedband superview super 7 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.
 
Manufacturer Narrative
Block h6: problem code 1069 relates to the reportable issue of trip wire broken.Block h10: 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 varicosity procedure performed on (b)(6) 2019.According to the complainant, prior to the procedure, it was noticed that the trip wire was abnormal.The procedure was completed with another speedband superview super 7 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) 2019.*** it was reported that procedure performed was esophageal variceal ligation (evl).
 
Manufacturer Narrative
Block h6: problem code 1069 relates to the reportable issue of trip wire broken.Block h10: investigation results received one speedband superview super 7, an extension tube and the ligator head for analysis.The device returned with its original shrink wrap.A visual evaluation noted that the the crimp was present on the trip wire.The trip wire was in good condition and was correctly placed in the handle assembly slot.There were seven bands found on the ligator head and were attached on their original positions.No damages were observed on the suture.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No visible issues were noted to the handle assembly and extension tube.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 varicosity procedure performed on (b)(6) according to the complainant, prior to the procedure, it was noticed that the trip wire was abnormal.The procedure was completed with another speedband superview super 7 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), 2019.*** it was reported that procedure performed was esophageal variceal ligation (evl).
 
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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 Key9519680
MDR Text Key189867166
Report Number3005099803-2019-06266
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 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/23/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0024158382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2020
Date Manufacturer Received02/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
Patient Weight58
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