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

Model Number M00566340

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event 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.During the procedure, when the jejunal tube was inserted via an endovive safety peg tube, the plastic tip detached inside the patient.The detached portion was retrieved endoscopically using forceps.Also, it was noticed that the jejunal tube was difficult to advance into the small intestine.They then decided to discontinue the placement.The procedure was completed with a non bsc device.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE JEJUNAL FEEDING TUBE
• Type of Device: 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: 11567546
• MDR Text Key: 244565611
• Report Number: 3005099803-2021-01037
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729789666
• UDI-Public: 08714729789666
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: M00566340
• Device Catalogue Number: 6634
• Device Lot Number: 0026097948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other