MAUDE Adverse Event Report: PEROUSE MEDICAL POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	4018PI
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is in transit for returned to perouse medical.We asked more information about the incident (lot, date implantation, venous access routes, implantation and explantation reports, copy of x-ray pictures for implantation and observation of event, the consequences for the patient, installer training).We are waiting for the device in order to perform a technical investigation.
Event or Problem Description
Port tubing became dislodged and migrated down to patient's heart.

• Brand Name: POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): PEROUSE MEDICAL; route du manoir; ivry le temple, 60173 ; FR 60173
• Manufacturer Contact: nathalie baude ; route du manoir; ivry le temple, 60173 ; FR 60173
• MDR Report Key: 18246344
• Report Number: 3004160911-2023-02977
• Device Sequence Number: 7116750
• Product Code: LJT
• UDI-Device Identifier: 03661234017638
• UDI-Public: 03661234017638
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K122834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4018PI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 70 KG