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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 M00542250
Device Problems Positioning Failure (1158); Failure to Fire (2610)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the patient identifier is (b)(6).(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 endoscopy with esophageal variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were entangled causing the bands to fail to deploy.Reportedly, the device was removed from the patient, and the procedure was completed with a different device.Additionally, the video clip sent in by the customer confirmed the alleged issue.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that a speedband superview super 7 device was used during an endoscopy with esophageal variceal ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were entangled causing the bands to fail to deploy.Reportedly, the device was removed from the patient, and the procedure was completed with a different device.Additionally, the video clip sent in by the customer confirmed the alleged issue.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block a1: it was reported that the patient identifier is (b)(6).Block h6: problem code 2610 for the reportable issue of bands failed to deploy.Block h10: investigation results received one speedband superview super 7 with the ligator head for analysis.It was noticed that the crimp was present on the trip wire and the trip wire was partially rolled in the handle assembly slot when received.A visual examination of the ligator head found five bands present which were moved out of their original positions with one band was caught under the other band.It was also noticed that the ligator teeth were bent.Additionally, the suture was observed to be intact.Media examination was performed and the attached video provided by the customer showed the device placed on the scope; the handle was rotated, then a band was moved out, but the device failed to deploy elastic bands, confirming the reported issue.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.Based on the evaluation of the returned complaint device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.It is most likely that the ligator head teeth were damaged due to handling and manipulation of the device during the procedure.Once the ligator head teeth are damaged, the suture can be detached from its position on the ligator head and this condition could have impacted the bands deployment activity, moving bands without being deployed, and contributing to the reported issues.Based on the information available and the analysis performed, it was concluded that the investigation conclusion code of this event is adverse event related to procedure, since adverse event occurred during the procedure and the device had no influence on event.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 Key9220602
MDR Text Key178740984
Report Number3005099803-2019-05167
Device Sequence Number1
Product Code MND
UDI-Device Identifier08714729201953
UDI-Public08714729201953
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 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/05/2020
Device Model NumberM00542250
Device Catalogue Number4225
Device Lot Number0023604446
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age10 YR
Patient Weight35
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