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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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2020
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 variceal ligation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the trip wire was ruptured.Reportedly, the device was removed, and 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 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 variceal ligation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the trip wire was ruptured.Reportedly, the device was removed, and 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 condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of tripwire broken.Block h10: investigation results: the returned speedband superview super 7 device was analyzed.It was also noted that the trip wire was not broken (as was reported), instead it was observed that the suture thread was broken.The trip wire was not secured and the slack was not taken up correctly.A functional evaluation revealed resistance to rotation, due to the tension on the trip wire.No other issues with the device were noted.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label: the visual assessment identified that the trip wire was not secured in the handle assembly, nor did the handle have evidence that the trip wire was previously secured.Not securing the trip wire in the handle slot could have caused the trip wire to slip through the handle assembly during deployment.The slack was not taken up correctly which provided extra tension on the device and may have led to the suture break.Taking all available information into consideration, the most probable root cause of this event is failure to follow instructions.A review of the device history record (dhr) 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 Key10118642
MDR Text Key194008149
Report Number3005099803-2020-02178
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 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/13/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0023787774
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age70 YR
Patient Weight65
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