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

Model Number	M00568211
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to the second of three endovive standard peg kit push used during the same procedure.It was reported to boston scientific corporation that an endovive standard peg kit push method was used during an esophagogastroduodenoscopy procedure performed on (b)(6) 2023.It was reported that when attempting to push the peg tube over the wire, it kept getting stuck where the introducer meets the peg tube.After multiple attempts to remove the peg tube which was stuck on the wire.The wire became unraveled and stretched.The device was removed from the patient.A second peg kit push method was opened however the same thing happened.The physician then used an endovive standard pull kit to complete the procedure.After the procedure, a third endovive standard peg push tube with the same lot was opened and the same thing occurred with the ones used previously.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.

• 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: 17890227
• Report Number: 3005099803-2023-05364
• Device Sequence Number: 6976547
• Product Code: KNT
• UDI-Device Identifier: 08714729285205
• UDI-Public: 08714729285205
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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 Model Number: M00568211
• Device Catalogue Number: 6821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown