MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE JEJUNAL FEEDING TUBE; TUBE, FEEDING

Model Number	M00566350
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device problem code a0501 captures the reportable event of peg tube detached.
Event or Problem Description
It was reported to boston scientific corporation that an endovive jejunal feeding tube was used during a gastrostomy jejunostomy procedure performed on (b)(6) 2023.It was reported on (b)(6) 2023 the g-tube was no longer attached to the adapter of the endovive jejunal feeding tube.A new endovive jejunal feeding tube was placed.There were no reported patient complications as a result of this event.

• Brand Name: ENDOVIVE JEJUNAL FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• 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: 16592917
• Report Number: 3005099803-2023-01515
• Device Sequence Number: 5088870
• Product Code: FPD
• UDI-Device Identifier: 08714729786252
• UDI-Public: 08714729786252
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K091340
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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: 12/07/2024
• Device Model Number: M00566350
• Device Catalogue Number: 6635
• Device Lot Number: 0030674370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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
• Patient Sex: Unknown