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

Model Number	M00568201
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation (bsc) that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) tube placement procedure performed on (b)(4) 2023.It was reported that the physicians were placing a peg tube endoscopically.As they pulled the peg tube through the stomach and abdominal wall, the peg tube went through the incision, resulting in an unsuccessful placement.A non-bsc clip was placed endoscopically to close the stoma site.No further information regarding this event has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
G2: medwatch reference number: 3302260000-2023-8013.H6: imdrf impact code f2301 captures the reportable event of additional device required (clip).Imdrf device code a051201 captures the reportable event of peg tube dislodged or dislocated.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18793310
• Report Number: 3005099803-2024-00712
• Device Sequence Number: 15527930
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2024

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: 11/30/2024
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0031857025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: White