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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 M00566470
Device Problems Obstruction of Flow (2423); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2024
Event Type  malfunction  
Event Description
Note: this report pertains to the first of four endovive safety peg kits push method used during the same procedure in the same patient.It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2024.It was reported that during tube placement, the guidewire would not pass through the transition zone between the connector of the peg tube.The same problem occurred with three more peg tubes.The procedure was completed with a pull method device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.
 
Event Description
Note: this report pertains to the first of four endovive safety peg kits push method used during the same procedure in the same patient.It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2024.It was reported that during tube placement, the guidewire would not pass through the transition zone between the connector of the peg tube.The same problem occurred with three more peg tubes.The procedure was completed with a pull method device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.Block h10: the customer reported that the device was disposed and will not be returned.As such, physical analysis has not been conducted in our laboratory.However, a device history review was performed and determined that, based on the nature of the reported event and the reported device lot number, the peg tube obstruction was likely the result of the manufacturing process.With all the available information, although the device has not been returned, boston scientific corporation (bsc) determined that the peg tube obstruction was likely caused by adhesive inside the hypo-tube of the transition joint.Adhesive is used during assembly, and it is likely that the obstruction was the result of incorrect placement or excessive use of adhesive, resulting in obstruction of the hypo tube.Bsc initiated a corrective and preventive action (capa) investigation to determine the root cause of this issue.Investigation identified a potential scenario in which the tip of the glue dispenser touches the threaded tip of the barb as it moves into position for glue and torque at the mini bolster.This could cause glue to migrate into the lumen of the barb component and cause a blockage.An initial containment was implemented on 05dec2023, and the pneumatic flow valve of the equipment was adjusted to ensure that the glue dispenser does not move into position until the barb is in the correct position, preventing the potential for this issue to reoccur.Additional corrections were implemented on 05feb2024 to add 100% pin gage inspection after the mini bolster step for push method device types.An investigation to address this problem has been completed.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
500 commander shea boulevard
quincy MA 02171
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18572622
MDR Text Key333618639
Report Number3005099803-2024-00118
Device Sequence Number1
Product Code KNT
UDI-Device Identifier08714729748397
UDI-Public08714729748397
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K031538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00566470
Device Catalogue Number6647
Device Lot Number0033112088
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number97172867-FA
Patient Sequence Number1
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