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 Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

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).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 peg kit was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2020, the entire peg tube had dislodged from the patient's stoma.Reportedly, the peg tube was not caught onto anything, it just dislodged.The patient was admitted to replace the dislodged peg tube.Consequently, the peg tube was replaced with a new peg tube on (b)(6) 2020.There were no reported patient complications 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: 11140896
• MDR Text Key: 225803683
• Report Number: 3005099803-2020-06632
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DUODOPA
• Patient Outcome(s): Other
• Patient Age: 75 YR