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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number M00566461
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and 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 a endovive safety peg kit pull method used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the peg tube was difficult to pull through the stoma.Reportedly, the peg tube was noted to be too short.The procedure was completed with a new endovive safety peg kit pull method.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a endovive safety peg kit pull method used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the peg tube was difficult to pull through the stoma.Reportedly, the peg tube was noted to be too short.The procedure was completed with a new endovive safety peg kit pull method.There were no patient complications reported as a result of this event.Additional information received on 04nov2020.This complaint was reported in error and is a duplicate of mdr id 3005099803-2020-05020.
 
Manufacturer Narrative
Block h6 (device codes): problem code 2920 captures the reportable event of peg tube difficult to advance.Block h6 (evaluation conclusion codes): the complainant indicated that the device was disposed and 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 SAFETY PEG KIT
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752 1242
MDR Report Key10791114
MDR Text Key214775063
Report Number3005099803-2020-05100
Device Sequence Number1
Product Code KNT
UDI-Device Identifier08714729802624
UDI-Public08714729802624
Combination Product (y/n)N
PMA/PMN Number
K031538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Model NumberM00566461
Device Catalogue Number6646
Device Lot Number0025245067
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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