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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
(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 two speedband superview super 7 devices were used during an esophageal varicose ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were attempted to be deployed, but the bands would not release.Reportedly, the device was removed from the patient and it was noted that the suture was not installed on the ligator cap.A second speedband device was used; however, the device fail to deploy elastic bands as there was no suture attached on the ligator head.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty setting up the devices.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
Initial reporter facility name: (b)(6) problem code 2907 captures the reportable issue of suture detached.Investigation results: the ligator head and irrigation catheter were only returned for analysis.Other components were not returned with the device.A visual examination of the ligator head found six bands present which were moved out of their original positions with some bands were caught under the other bands.It was also noticed that the ligator teeth were bent.It was also possible to observe that the suture was attached to the ligator head and an additional knot was found on the suture loop, confirming the reported failure of suture detached.Based on the evaluation of the returned 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.Also, the suture can tangle with the bands which can result in difficulty to rotate the handle and continued attempts to deploy the bands can result in suture breakage.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause 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.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 two speedband superview super 7 devices were used during an esophageal varicose ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were attempted to be deployed, but the bands would not release.Reportedly, the device was removed from the patient and it was noted that the suture was not installed on the ligator cap.A second speedband device was used; however, the device fail to deploy elastic bands as there was no suture attached on the ligator head.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty setting up the devices.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, HEMORRHOIDAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9246413
MDR Text Key178751183
Report Number3005099803-2019-05249
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 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/09/2020
Device Model NumberM00542251
Device Catalogue Number4225
Device Lot Number0023928115
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Date Manufacturer Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
Patient Weight67
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