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

Model Number M00566320

Device Problems Difficult to Remove (1528); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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 Description

It was reported to boston scientific corporation that an endovive three-port through the peg jejunal tube was being used during a gastrostomy placement procedure performed on (b)(6) 2022.During the procedure, the jejunal tube was inserted along with the guidewire.It was then attempted to remove the guidewire however, it was unable to do so therefore the jejunal tube as well as the guidewire was removed.The guidewire was checked outside the body and found it was deformed which caused it not to be able to be removed from the jejunal tube.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: one endovive jejunal tube and a guidewire were returned.During product analysis was observed that the working length present kinks.The guidewire was kinked at the tip and can't be removed.Therefore, the reported complaint was confirmed.In addition, the sheath of the guidewire was buckled.Based on the condition of the returned device, engineers determined that the problem observed could be due to the manipulation, anatomical conditions and technique used at the time to interact with the device, which could have kinked the working length and damage the tip of the guide wire.It was reported that the tip part was grasped by the snare indicating the cause of the tip damage and why it could not be removed from the j-tube.The sheath buckled of the guide wire is a sign of the complications that the device had to go through.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on the event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an endovive three-port through the peg jejunal tube was being used during a gastrostomy placement procedure performed on (b)(6) 2022.During the procedure, the jejunal tube was inserted along with the guidewire.It was then attempted to remove the guidewire however, it was unable to do so therefore the jejunal tube as well as the guidewire was removed.The guidewire was checked outside the body and found it was deformed which caused it not to be able to be removed from the jejunal tube.The procedure was cancelled due to this event.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: 13360331
• MDR Text Key: 287124238
• Report Number: 3005099803-2022-00258
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729786313
• UDI-Public: 08714729786313
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: M00566320
• Device Catalogue Number: 6632
• Device Lot Number: 0027948968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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