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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY Back to Search Results
Model Number M00568470
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2020
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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when one step button loop wire was pulled, the tip separated.The device was removed and procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6 (device codes): problem code 2907 captures the reportable event of one step button delivery system detached.Block h10: visual analysis of the device revealed that one step button assembly was returned for analysis.The button was not release and dilating tip detached from the tubing.The reported complaint was confirmed.In addition, the c-flex tubing was stretched.It is most likely that procedural and anatomical factors encountered during the procedure could have affected the device performance and its integrity.Probably the c-flex tubing was separated due to user technique, patient anatomy or other procedural factors such the incision size, the force applied to pull the device during placement could have contributed with the event, stretching material on the c-flex tubing suggests that the component was submitted to tensile force during its use.Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Event Description
It was reported to boston scientific corporation that an endovive one step button was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when one step button loop wire was pulled, the tip separated.The device was removed and procedure was completed with a new endovive one step button.There were no patient complications reported as a result of this event.
 
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Brand Name
ENDOVIVE ONE STEP BUTTON
Type of Device
TUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key10829124
MDR Text Key215909976
Report Number3005099803-2020-05300
Device Sequence Number1
Product Code KGC
UDI-Device Identifier08714729149217
UDI-Public08714729149217
Combination Product (y/n)N
PMA/PMN Number
K910584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2022
Device Model NumberM00568470
Device Catalogue Number6847
Device Lot Number0025169812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Date Manufacturer Received01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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