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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number M00509181
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2023
Event Type  malfunction  
Manufacturer Narrative
Block e1 (initial reporter city): (b)(6).Block h6 (device codes): imdrf device code a0414 captures the reportable event of peg tube torn.
 
Event Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy tube placement procedure on (b)(6) 2023.It was reported that, post procedure on (b)(6) 2023, the peg tube was torn.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 an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy tube placement procedure on (b)(6) 2023.It was reported that, post procedure on (b)(6) 2023, the peg tube was torn.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.
 
Manufacturer Narrative
Block e1 (initial reporter city): (b)(6).Block h6 (device codes): the returned endovive safety peg tube was analyzed, and a visual analysis noted that the distal section of the silicone tube was found to have evidence of detachment.Microscopic analysis confirmed the evidence of detachment in the distal section.No other problems with the device were noted.The reported event of peg tube torn could not be confirmed as the silicon tube was not torn on the returned device.However, during product analysis, it was determined that the device was returned with evidence of detachment in the distal section.It is possible that procedural factors such as lesion characteristics, handling of the device, and/or the technique and force used by the physician could have resulted in the physical damage to the device.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
 
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Brand Name
ENDOVIVE SAFETY PEG KIT
Type of Device
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key17882018
MDR Text Key325090782
Report Number3005099803-2023-05184
Device Sequence Number1
Product Code PIF
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K150679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00509181
Device Catalogue Number57708
Device Lot Number0031309546
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2023
Initial Date FDA Received10/05/2023
Supplement Dates Manufacturer Received10/25/2023
Supplement Dates FDA Received11/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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