Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00509171
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2022
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an endovive securi-t was used during gastrostomy replacement procedure.The procedure date is unknown.During the procedure, when removing the placed device the internal bolster detached and only the tube was removed.The procedure was completed with a new endovive securi-t percutaneous replacement gastrostomy tube.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Date of event was approximated to (b)(6) 2022 as no event date was reported.(b)(4).
 
Event Description
It was reported to boston scientific corporation that an endovive securi-t was used during gastrostomy replacement procedure.The procedure date is unknown.During the procedure, when removing the placed device the internal bolster detached and only the tube was removed.The procedure was completed with a new endovive securi-t percutaneous replacement gastrostomy tube.There were no patient complications reported as a result of this event.Additional information received on november 24, 2022.The detached internal bolster in the patient and was retrieved.
 
Manufacturer Narrative
Block b3 (date of event): date of event was approximated to 11/01/2022 as no event date was reported.Block h6 (device codes): device code a0501 captures the reportable event of internal bolster detached.Block h6 (impact codes): impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2301 captures the reportable event of additional device required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOVIVE SECURI-T
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15825325
MDR Text Key307189850
Report Number3005099803-2022-06806
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00509171
Device Catalogue Number0917
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2022
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
Patient Sequence Number1
Patient Outcome(s) Other;
-
-