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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00568151
Device Problems Detachment of Device or Device Component (2907); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.(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 securi-t percutaneous replacement gastrostomy tube was used during a feeding tube replacement procedure.The procedure date is unknown.According to the complainant, during removal of the placed device, the internal bolster detached and became dislodged.Reportedly, the detached internal bolster was excreted.The date is unknown.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that an endovive security percutaneous replacement gastrostomy tube was used during a feeding tube replacement procedure.The procedure date is unknown.According to the complainant, during removal of the placed device, the internal bolster detached and became dislodged.Reportedly, the detached internal bolster was excreted.The date is unknown.There were no patient complications reported as a result of this event.Additional information received on 22nov2019: it was replaced with a new endovive security percutaneous replacement gastrostomy tube.
 
Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.(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.
 
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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
MDR Report Key9262795
MDR Text Key164616984
Report Number3005099803-2019-05324
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
PMA/PMN Number
K961345
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00568151
Device Catalogue Number6815
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/04/2019
Initial Date FDA Received10/31/2019
Supplement Dates Manufacturer Received11/20/2019
Supplement Dates FDA Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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