MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE ONE STEP BUTTON; TUBE, GASTRO-ENTEROSTOMY

Model Number	M00568520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(date of event): date of event was approximated to (b)(6) 2022 as no event date was reported.Medical device problem code a0401 captures the reportable event of pull wire broken.
Event or Problem Description
It was reported to boston scientific corporation that a one step button pull kit was used during a gastrostomy procedure.It was reported that there was a case in which the loop attached to the tip of this device was torn.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE ONE STEP BUTTON
• Common Device Name: TUBE, GASTRO-ENTEROSTOMY
• 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: 16130025
• Report Number: 3005099803-2023-00049
• Device Sequence Number: 7673725
• Product Code: KGC
• UDI-Device Identifier: 08714729149231
• UDI-Public: 08714729149231
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2023

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 Expiration Date: 01/05/2024
• Device Model Number: M00568520
• Device Catalogue Number: 6852
• Device Lot Number: 0026723787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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
• Patient Sex: Unknown