MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568211

Device Problems Obstruction of Flow (2423); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.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 two endovive standard peg kit push method used during the same procedure.It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure.The procedure date is unknown.It was reported that when attempting to push the peg tube over the wire, the guidewire would not pass through where the introducer meets the peg tube.A second peg kit was opened and had the same problem.The procedure was completed with a different device and no further devices were used.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: 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 (b)(6) 2023, 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 (b)(6) 2024 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.

Event Description

Note: this report pertains to the first of two endovive standard peg kit push method used during the same procedure.It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure.The procedure date is unknown.It was reported that when attempting to push the peg tube over the wire, the guidewire would not pass through where the introducer meets the peg tube.A second peg kit was opened and had the same problem.The procedure was completed with a different device and no further devices were used.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE STANDARD 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18023291
• MDR Text Key: 327735123
• Report Number: 3005099803-2023-05802
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729285205
• UDI-Public: 08714729285205
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• 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 Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00568211
• Device Catalogue Number: 6821
• Device Lot Number: 0032151880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 97172867-FA
• Patient Sequence Number: 1