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

Model Number	M00566350
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(device codes): device problem code a1409 captures the reportable event of peg tube obstructed.
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.The jejunal tube became obstructed on (b)(6) 2023.A new endovive jejunal feeding tube was placed.There were no reported patient complications as a result of this event.
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.The jejunal tube became obstructed on (b)(6) 2023.A new endovive jejunal feeding tube was placed.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a1409 captures the reportable event of peg tube obstructed.Block h10: one endovive jejunal feeding tube was returned for analysis.The device was inspected and no problem found.Functional inspection showed that water was injected into the device which leaves the device without any problem.Therefore, the reported complaint is not confirmed.Based on a review of all available information, the cause of the reported event could not be determined.The product record review results and external support form meets all manufacturing specifications required and passed all the controls and inspections; no abnormalities were reported during the manufacturing process.Since the investigation findings do not lead to a clear conclusion about the cause of the reported event, no problem detected is selected as the most probable cause for the complaint.Block h11: correction: block b1 adverse event/product problem and block b2 outcomes attrib to adv event have been updated based on review of the complaint record.Block h1 type of reportable event has been updated from serious injury to malfunction.Block h2 correction has been added.

• 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: 16597344
• Report Number: 3005099803-2023-01371
• Device Sequence Number: 14847060
• 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,Followup
• Report Date (Section B): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown