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

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2021 as no event date was reported.The reported lot number 26268500 does not match to any upn and the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).

Event Description

Note: this report pertains to seven endovive peg kits.Refer to manufacturer report# 3005099803-2021-05723, 3005099803-2021-05724, 3005099803-2021-05725, 3005099803-2021-05727, 3005099803-2021-05728 and 3005099803-2021-05729 for the associated device information.It was reported to boston scientific corporation that an endovive peg kit was used during a percutaneous endoscopic gastrostomy (peg) placement procedure.The procedure date is unknown.It was reported that the patients were not pulling the peg tubes out of their stoma sites but rather they were loose and falling out of the patients.A new peg tube was placed.

• 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: 12743786
• MDR Text Key: 279823713
• Report Number: 3005099803-2021-05726
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 10/08/2021
• 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