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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENODVIVE GASTROSTOMY TUBE; TUBES, GASTRROINTESTINAL ( AND ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION ENODVIVE GASTROSTOMY TUBE; TUBES, GASTRROINTESTINAL ( AND ACCESSORIES) Back to Search Results
Model Number SEE UPLOADED PHOTOGRAPH OF LABEL
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2019
Event Type  Injury  
Event Description
The patient was undergoing gastrotomy tube placement.Initially, a 24 french boston scientific endo vive peg kit was not used.During the initial attempts to pull through the peg tube, the procedure failed due to separation of the tube into 2 parts while being pulled through the stomach and abdominal wall.The wire was salvaged and the gastrotomy tube pieces were removed.Subsequently a cook 24 french gastrostomy tube was placed without difficulty.Of note this happened to me on another patient and several of my partners also experienced the same problem in their practice.Fda safety report id # (b)(4).
 
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Brand Name
ENODVIVE GASTROSTOMY TUBE
Type of Device
TUBES, GASTRROINTESTINAL ( AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
marlborough MA 01752
MDR Report Key9249798
MDR Text Key164483014
Report NumberMW5090735
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 10/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2021
Device Model NumberSEE UPLOADED PHOTOGRAPH OF LABEL
Device Catalogue NumberM00566100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age12 DA
Patient Weight75
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