MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	M00509041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used in the stomach during an esophagogastroduodenoscopy (egd) with peg placement procedure performed on (b)(6) 2024.During the procedure, moderate sedation was applied to the patient.It was observed that the pull wire broke off as it was pulled through the incision.The physician was unable to complete the procedure, and the peg tube remained inside the patient.The patient was transferred to a short-term acute care (stac) hospital and the same physician completed the procedure under general anesthesia.The peg tube was removed and replaced with a new peg tube.It was reported that the patient was okay.The procedure was completed with a different endovive standard peg kit.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6 (impact codes): impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Block h6: (device code) imdrf device code a0401 captures the reportable event of pull wire broken.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 20352350
• Report Number: 3005099803-2024-04775
• Device Sequence Number: 18125588
• Product Code: PIF
• UDI-Device Identifier: 08714729880479
• UDI-Public: 08714729880479
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150679
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: 04/10/2026
• Device Model Number: M00509041
• Device Catalogue Number: 57706
• Device Lot Number: 0034262805
• 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: 09/06/2024
• Initial Report FDA Received Date: 10/02/2024
• Date Device Manufactured: 06/18/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 86 KG