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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 M00568530
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2020
Event Type  Injury  
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 mdr 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 on (b)(6) 2020. According to the complainant, during the procedure, the internal bolster detached inside the patient's stomach. Reportedly, the detached portion was removed. There were no reported patient complications as a result of this event. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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Brand NameENDOVIVE ONE STEP BUTTON
Type of DeviceTUBE, GASTRO-ENTEROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 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 Key10613128
MDR Text Key209375143
Report Number3005099803-2020-04321
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K910584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/12/2022
Device Model NumberM00568530
Device Catalogue Number6853
Device Lot Number0023838932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/01/2020 Patient Sequence Number: 1
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