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); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
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
Note: this report pertains to one of two endovive safety peg kit push method used in the same patient and procedure.It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) feeding tube insertion and egd (esophagogastroduodenoscopy) procedure performed on (b)(6) 2024.A peg tube exchange was performed due to leakage of the device that was placed three months prior.During the procedure, when the physician exchanged the tube, the guidewire would not pass through the peg tube despite many efforts.They tried cutting the guidewire to remove the kink as well as straightening and maneuvering the tube to try to get the wire to pass.A second peg kit was opened but the same problem occurred.The procedure was completed with an endovive safety peg kit pull method.There were no patient complications reported as a result of this event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20790818
• Report Number: 3005099803-2024-06008
• Device Sequence Number: 15161907
• Product Code: KNT
• UDI-Device Identifier: 08714729748397
• UDI-Public: 08714729748397
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 06/30/2025
• Device Model Number: M00566470
• Device Catalogue Number: M00566470
• Device Lot Number: 0033158826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/27/2024
• Date Device Manufactured: 06/21/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97172867-FA
• Patient Sequence Number: 1
• Patient Sex: Unknown