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

Model Number	M00568201
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0413 captures the reportable event of material separation.Imdrf impact code f23 captures the reportable event of unexpected medical intervention (transfer to another healthcare facility).
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used in a procedure.The exact procedure date was unknown.During the procedure, before closing the incision, they noticed the white sheath cover of the needle and the orange hub (all one piece used as trocar) had detached and come out in the peritoneum of the patient.An attempt was made to remove it from the patient, but it was unsuccessful.The patient was transferred to another healthcare facility where the detached piece was successfully retrieved from the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0413 captures the reportable event of material separation.Imdrf impact code f23 captures the reportable event of unexpected medical intervention (transfer to another healthcare facility).Imdrf impact code f19 captures the reportable event of surgical intervention (interventional radiology procedure).
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used in a procedure.The exact procedure date was unknown.During the procedure, before closing the incision, they noticed the white sheath cover of the needle and the orange hub (all one piece used as trocar) had detached and come out in the peritoneum of the patient.An attempt was made to remove it from the patient, but it was unsuccessful.The patient was transferred to another facility where the detached piece was successfully retrieved from the patient.There were no patient complications reported as a result of this event.**additional information received january 29, 2025** it was reported that the patient underwent an interventional radiology procedure and returned to the nursing home with no incision or dressing to the abdomen.

• Brand Name: ENDOVIVE STANDARD 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21173323
• Report Number: 3005099803-2025-00077
• Device Sequence Number: 19901888
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2025
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0032938106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/23/2025
• Date Device Manufactured: 11/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown