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

Model Number	M00566460
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a051201 captures the reportable event of peg tube dislodged or dislocated.Block h6 (patient codes): patient code e1906 captures the reportable event of infection.Block h6 (impact codes): impact code f2303 captures the reportable event of medication required.Impact code f19 captures the reportable event of surgical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy placement procedure.The procedure date is unknown.The procedure was completed with the original device.Post procedure, the peg tube became dislodged and caused an infection in the stomach.The device was removed (b)(6) 2023.It was reported that the patient was given an antibiotic to resolve the infection.

• 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: 16772330
• Report Number: 3005099803-2023-02068
• Device Sequence Number: 3250964
• Product Code: KNT
• UDI-Device Identifier: 08714729748380
• UDI-Public: 08714729748380
• 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
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

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: 07/31/2024
• Device Model Number: M00566460
• Device Catalogue Number: 6646
• Device Lot Number: 0030982595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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: Other
• Patient Sex: Male