MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE Y-PORT FEEDING ADAPTER; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number M00566471

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

Note: this report pertains to the third of three endovive safety peg kits push method that were used in the same patient and procedure.It was reported to boston scientific corporation that an endovive safety peg kit push method was attempted to be used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2024.During the procedure, the guidewire could not pass through the transition zone between the connector, between the hard and soft plastic.The customer reported that two additional peg kits were opened and attempted to be used but the same problem occurred.The procedure was completed with the third pull method peg kit.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a1409 captures the reportable event of peg tube obstructed.

Event Description

Note: this report pertains to the third of three endovive safety peg kits push method that were used in the same patient and procedure.It was reported to boston scientific corporation that an endovive safety peg kit push method was attempted to be used during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2024.During the procedure, the guidewire could not pass through the transition zone between the connector, between the hard and soft plastic.The customer reported that two additional peg kits were opened and attempted to be used but the same problem occurred.The procedure was completed with the third pull method peg kit.There were no patient complications reported as a result of this event.Additional information was received on march 08, 2024: it was reported that they only had problems with two endovive safety peg kit push method and completed the procedure with a pull method peg kit.There are no complaint allegations on the third device.

Manufacturer Narrative

Block h10: it was reported that they only had problems with two endovive safety peg kit push method and completed the procedure with a pull method peg kit.There are no complaint allegations on the third device.The two endovive safety peg kit push will be captured under mdr# 3005099803-2024-00893 and mdr# 3005099803-2024-00894.

• Brand Name: ENDOVIVE Y-PORT FEEDING ADAPTER
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18860721
• MDR Text Key: 337206284
• Report Number: 3005099803-2024-00896
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 08714729802631
• UDI-Public: 08714729802631
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00566471
• Device Catalogue Number: 6647
• Device Lot Number: 0033113029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 97172867-FA
• Patient Sequence Number: 1