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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.
 
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Brand NameENDOVIVE ONE STEP BUTTON
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key10829124
MDR Text Key215909976
Report Number3005099803-2020-05300
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K910584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
0 Patients were 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
Device Model NumberM00568470
Device Catalogue Number6847
Device Lot Number0025169812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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