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

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/05/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an endovive peg kit was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2022.During the procedure, the loop wire at the end of the peg tube broke off while being pulled through the stoma site.The procedure was completed with this device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an endovive peg kit was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2022.During the procedure, the loop wire at the end of the peg tube broke off while being pulled through the stoma site.The procedure was completed with this device.There were no patient complications reported as a result of this event.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13618784
• MDR Text Key: 286241302
• Report Number: 3005099803-2022-00984
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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