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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, ESOPHAGEAL Back to Search Results
Model Number M00542251
Device Problems Premature Activation (1484); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter name and address: (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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a varicosity procedure performed on (b)(6) 2021.During the procedure, it was reported that the bands were not deployed in the correct sequence and were released in the opposite direction.It was noted that there was no difficulty experienced upon setting up the device.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 e1 (initial reporter facility name): (b)(6).Block h6: medical device code a150103 captures the reportable issue of the bands were not deployed by correct sequence.Block h10: investigation results: the returned speedband superview super 7 device was analyzed, and a visual evaluation noted that the handle assembly and ligator head were returned with the device.It was noted that the handle assembly presented marks indicating that the trip wire was secured, and the slack was correctly taken up.It was also noticed that the trip wire had several kinks.The ligator head returned with all the bands attached and some of them were moved out from their original position and were overlapped.Further inspection shows that the ligator head teeth were damaged and the suture thread was correctly positioned on the ligator head.A functional evaluation was performed by rotating the handle knob 180 degrees, it could be rotated without any issues.No other issues with the device were noted.The reported event was not confirmed.The ligator head returned with all bands attached which indicates there was not a deployment of bands or a deployment out of sequence.Additionally, the suture was found to be correctly positioned on the ligator head and showed no signed of being misassembled.However, the bands were overlapped and moved from their position indicating a deployment failure.This could be related to the observed ligator head teeth damage and may have been generated due to user manipulation while setting up and/or extra tension applied to the device.Once the teeth are damaged, the suture thread can experience difficulties releasing the bands.Additionally, the trip wire was found kinked.This could have occurred due to user manipulation or technique used during the procedure.Taking all available information into consideration, the most probable root cause of this complaint is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.).
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a varicosity procedure performed on (b)(6) 2021.During the procedure, it was reported that the bands were not deployed in the correct sequence and were released in the opposite direction.It was noted that there was no difficulty experienced upon setting up the device.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.
 
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Brand Name
SPEEDBAND SUPERVIEW SUPER 7
Type of Device
LIGATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12246978
MDR Text Key264354836
Report Number3005099803-2021-03816
Device Sequence Number1
Product Code MND
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,distri
Type of Report Initial,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/13/2022
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0026628880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2021
Date Manufacturer Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age51 YR
Patient Weight66
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