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

Model Number	M00566320
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an endovive three port through the peg jejunal tube was used during a jejunal tube placement procedure.The exact procedure date was unknown however it was reported that it was placed approximately three months ago.According to the complainant after many weeks the jejunal tube became clogged.There were no patient complications reported 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
• MDR Report Key: 8040389
• Report Number: 3005099803-2018-61229
• Device Sequence Number: 19198761
• Product Code: KNT
• UDI-Device Identifier: 08714729786313
• UDI-Public: 08714729786313
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: M00566320
• Device Catalogue Number: 6632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1