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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 M00563120
Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 as no event date was reported. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, 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. The procedure date is unknown. According to the complainant, the peg tube has a hole and it was leaking. 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 Key10157982
MDR Text Key195275636
Report Number3005099803-2020-02323
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K910584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00563120
Device Catalogue Number6312
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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