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

Model Number	M00566470
Medical Device Problem Codes	Obstruction of Flow (2423); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1409 captures the reportable event of peg tube obstructed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit push method was used in the esophagus and stomach during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2025.During the procedure, upon initial placement of the device, the physician tried to pass the push peg tube over the guidewire, but the tube would not pass due to obstruction within the tube.The procedure was completed with another endovive safety peg kit push method.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit push method was used in the esophagus and stomach during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2025.During the procedure, upon initial placement of the device, the physician tried to pass the push peg tube over the guidewire, but the tube would not pass due to obstruction within the tube.The procedure was completed with another endovive safety peg kit push method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1409 captures the reportable event of peg tube obstructed.Block h11: (investigation results).The returned endovive safety peg kit push method was analyzed.The push gastrodome assembly was received in two pieces.Visual inspection noted that there was a cut at the barb connector joint.There were no kinks observed along the tubing.During functional testing, a 0.018 inch guidewire was used and was not able to pass through the feeding tube.Additionally, adhesive was found blocking the barb connector joint.No other problems with the device were noted.With all the available information, boston scientific corporation (bsc) concludes the reported event of peg tube obstruction was confirmed.The peg tube obstruction was likely caused by the 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 problem.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.Further corrective implementations such as improving the process and equipment control in product assembly were implement (b)(6) 2024.An investigation to address this problem has been completed.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Common Device Name: 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21314291
• Report Number: 3005099803-2025-00308
• Device Sequence Number: 21044687
• Product Code: KNT
• UDI-Device Identifier: 08714729748397
• UDI-Public: (01)08714729748397(17)250331(10)33112089
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: M00566470
• Device Catalogue Number: M00566470
• Device Lot Number: 0033112089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown