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

Model Number UNK-P-INITIAL_G-TUBE_-_ENTERAL_FEEDING

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020 as no event date was reported.The complainant was unable to provide the device upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; therefore a failure 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.The procedure date is unknown.According to the complainant, the patient reported peg tube leakage.Reportedly, the patient is scheduled for replacement (unknown date).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: 10324453
• MDR Text Key: 200404256
• Report Number: 3005099803-2020-02949
• 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: 07/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-P-INITIAL_G-TUBE_-_ENTERAL_FEEDING
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• 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