MAUDE Adverse Event Report: PEROUSE MEDICAL POLYSITE IMPLANTABLE INFUSION PORTS

Model Number 4018PI

Device Problems Disconnection (1171); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 10/24/2023

Event Type  Injury  

Event Description

Port tubing became dislodged and migrated down to patient's heart.Patient was stable post port and tubing removal.

Manufacturer Narrative

The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are pending and will be communicated to fda within 30 days of its conclusion via follow up mdr.

Manufacturer Narrative

We received one used sample for evaluation.The device received is composed of the implantable port, the catheter (25.3 cm), and its ring.The serial number of the returned port is (b)(4).We managed to trace lot number 23010086 using the serial lot.According to the available information and our experience, we believe that the most likely hypothesis that could explain the catheter disconnection from the implantable port could be excessive pressure in the device, following a phenomenon of obstruction, leading to the disconnection of the catheter and its migration.The titanium outlet tube shows severe damage, (pinched and cracked).We assume that this damage was generated during the removal of the port, as otherwise, the surgeon would not have been able to connect the catheter.Dimensional tests have been performed on the catheter and the ring: the results are compliant with specifications.Functional tests performed on the catheter and the port are compliant.However, during this test, we observed the presence of blood in significant quantities, especially coagulated blood in the catheter.The risk of damage to the catheter during attempting to unblock under pressure is clearly described in the instruction for use (ifu # cd00632/003) of polysite (section iii-a warning and precautions).Extract: « never try to unblock the device by pressure and never use a syringe smaller than 10 ml to avoid applying excessive pressure within the device.Excessive pressure can damage the catheter or lead to disconnection of the port».Furthermore, to avoid any obstruction of the catheter by blood, positive pressure must be systematically applied when removing the needle.Indeed, the absence of injection causes blood reflux in the catheter which can lead to its obstruction.The review of the manufacturing batch record of the polysite (b)(4) implantable port final product (lot 23010086) did not highlight any deviation that could be the root cause of the incident.Based on vygon usa complaint database (grand avenue), this is the first complaint received regarding this product code and lot number.Corrective action: based on the investigation, the root cause of this complaint could be excessive pressure in the device, leading to the disconnection of the catheter.Therefore, no further corrective action was initiated by quality management.

Event Description

Port tubing became dislodged and migrated down to patient's heart.Patient was stable post port and tubing removal.

• Brand Name: POLYSITE IMPLANTABLE INFUSION PORTS
• Type of Device: POLYSITE IMPLANTABLE INFUSION PORTS
• Manufacturer (Section D): PEROUSE MEDICAL; route du manoir; ivry, le temple PA 60173 ; FR 60173
• Manufacturer (Section G): PEROUSE MEDICAL; route du manoir; ivry, le temple 60173 ; FR 60173
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 18104804
• MDR Text Key: 327775271
• Report Number: 2245270-2023-00080
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4018PI
• Device Lot Number: 23010086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 70 KG