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

Model Number	M00566320
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem 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 used during a jejunal tube placement procedure performed on (b)(6) 2021.According to the complainant, post procedure, fluoroscopy was performed to confirm the placement of the device.It was found that the contrast was in the stomach as well as in the duodenum.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a0504 captures the reportable event of feeding tube leaked.Problem code a0414 captures the reportable event of feeding tube split/torn.Block h10: the returned endovive jejunal feeding tube was analyzed.A visual evaluation noted there were no tears in the device.A functional evaluation noted when saline solution was injected through the device using a syringe, no leakages were found indicating that the tube did not have any tears.No other problems with the device were noted.The reported complaint was not confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities related to the reported event were identified during the manufacturing process; during testing of the unit returned it was determined that device did not have any visual damage/defect and no leakages were observed during functional evaluation; the unit returned did not show evidence of either the alleged problems or any defect which could have contributed to the event, therefore, it was concluded that the investigation conclusion code for the complaint will be documented as no problem detected since the device complaint or problem cannot be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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 performed on (b)(6) 2021.According to the complainant, post procedure, fluoroscopy was performed to confirm the placement of the device.It was found that the contrast was in the stomach as well as in the duodenum.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 11307590
• Report Number: 3005099803-2021-00479
• Device Sequence Number: 3383747
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 03/27/2021
• Device Model Number: M00566320
• Device Catalogue Number: 6632
• Device Lot Number: 0023555755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1