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

Model Number	M00566320
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time. problem code 2976 captures the reportable event of peg tube kinked.The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive three-port through the peg jejunal tube was being used during a procedure.The exact procedure date is unknown; however, it was reported that the device was in use for a month.According to the complainant, the jejunal tube was checked during a regular replacement.During the check up, they were able to advance the guidewire but the water could not be introduced as the tip of the tube was kinked.The procedure was completed with a new endovive three-port through the peg jejunal tube.There were no patient complications reported due to this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4).Visual examination of the returned device revealed no visual defects.The device looks under good conditions without evidence of damages or anomalies.The product was specifically inspected for kinked or flattened sections and none of these failures were detected.The complaint was not consistent with the reported event of kinked feeding tube.Based on all gathered information, therefore, it was concluded that the investigation conclusion code of this event is no problem detected since the device complaint or problem cannot be confirmed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive three-port through the peg jejunal tube was being used during a procedure.The exact procedure date is unknown; however, it was reported that the device was in use for a month.According to the complainant, the jejunal tube was checked during a regular replacement.During the check up, they were able to advance the guidewire but the water could not be introduced as the tip of the tube was kinked.The procedure was completed with a new endovive three-port through the peg jejunal tube.There were no patient complications reported due to this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 7899342
• Report Number: 3005099803-2018-60536
• Device Sequence Number: 18874019
• Product Code: KNT
• UDI-Device Identifier: 08714729786313
• UDI-Public: 08714729786313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: 57975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement 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