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 Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

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 was disposed and will not be returned for evaluation; 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 on (b)(6), 2019.According to the complainant, on (b)(6), 2020, the patient had redness and pus at the stoma site.On (b)(6), 2020, the patient went to urgent care and was prescribed oral doxycycline.On (b)(6), 2020, stoma site was very swollen, bleeding and had some skin peeling.The patient went to the emergency room and was admitted for cellulitis of the stoma site.That evening, due to swelling, the peg/jejunal tube came out on its own and stoma site was red around 4 to 5 inches.A wound culture was done and showed positive for pseudomonas.The patient had a fever and was given ciprofloxacin hcl 500 m twice daily for five days.In addition, the patient was given unknown other treatments.The duodopa was put on hold.(b)(6), 2020, the patient was discharged.Reportedly, the patient went to her primary care physician and the oral ciprofloxacin was extended for 10 days.Currently the patient is only taking oral medications and there is no tubing in place.The patient will be following up with a gastroenterologist to determine if the tubing can be replaced.

• 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: 10207146
• MDR Text Key: 197287432
• Report Number: 3005099803-2020-02490
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• 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: 06/01/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 66 YR