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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 12FR X 68CM ENDOVIVE TTP JEJUNAL FEEDING PIGTAIL TIP; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION 12FR X 68CM ENDOVIVE TTP JEJUNAL FEEDING PIGTAIL TIP; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number LOG2359435
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem Failure of Implant (1924)
Event Date 01/31/2023
Event Type  malfunction  
Event Description
Patient status post gj (gastrostomy-jejunostomy) tube placement on [redacted date] in cae.[redacted date] - due to gj tube being clogged, patient s/p replacement gj tube replacement in cae.[redacted date] - due to external tubing of g tube no longer being attached to the adapter, patient s/p gj tube replacement in cae [redacted date] - leak from adapter which appears to be a defect in plastic [redacted date] - gi team applied dermabond to adapter.Unknown as of yet whether this has fixed the leak.Concern for product malfunction/defect.
 
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Brand Name
12FR X 68CM ENDOVIVE TTP JEJUNAL FEEDING PIGTAIL TIP
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key16435150
MDR Text Key310173116
Report Number16435150
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberLOG2359435
Device Lot Number30674370
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2023
Event Location Hospital
Date Report to Manufacturer02/24/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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