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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 M00566460
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complainant indicated that the device was implanted 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 an endovive safety peg pull method was placed during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, peg tube tip detached.The procedure was completed with this device.There were no reported patient complications as a result of this event.
 
Event Description
It was reported to boston scientific corporation that an endovive safety peg pull method was placed during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, peg tube tip detached.The procedure was completed with this device.There were no reported patient complications as a result of this event.
 
Manufacturer Narrative
Block h6 (device codes): problem code 2907 captures the reportable event of the peg tube detached.Block h6 (evaluation conclusion codes): the complainant indicated that the device was implanted 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.Block h11 (correction): the manufacturing site address in section g has been corrected (mfr site address 1, mfr site city, mfr site state, mfr site zip/post code).
 
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Brand Name
ENDOVIVE SAFETY PEG KIT
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10885100
MDR Text Key226367149
Report Number3005099803-2020-05551
Device Sequence Number1
Product Code KNT
UDI-Device Identifier08714729748380
UDI-Public08714729748380
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 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2021
Device Model NumberM00566460
Device Catalogue Number6646
Device Lot Number0025925659
Was Device Available for Evaluation? No
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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