MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number M00509010

Device Problem Obstruction of Flow (2423)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

Note: this report pertains to the third of three endovive safety peg kits push method that were used in the same patient and procedure.It was reported to boston scientific corporation that an endovive safety peg kit push method was attempted to be used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2024.During the procedure, the guidewire could not pass through the transition zone between the connector, between the hard and soft plastic.The customer reported that two additional peg kits were opened and attempted to be used but the same problem occurred.The procedure was completed with a fourth endovive safety peg kit push method.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a1409 captures the reportable event of peg tube obstructed.

Event Description

Note: this report pertains to the third of three endovive safety peg kits push method that were used in the same patient and procedure.It was reported to boston scientific corporation that an endovive safety peg kit push method was attempted to be used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2024.During the procedure, the guidewire could not pass through the transition zone between the connector, between the hard and soft plastic.The customer reported that two additional peg kits were opened and attempted to be used but the same problem occurred.The procedure was completed with a fourth endovive safety peg kit push method.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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 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.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18800174
• MDR Text Key: 336533889
• Report Number: 3005099803-2024-00716
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 08714729880400
• UDI-Public: 08714729880400
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509010
• Device Catalogue Number: 57707
• Device Lot Number: 0032960811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 97172867-FA
• Patient Sequence Number: 1