MAUDE Adverse Event Report: PEROUSE MEDICAL POLYSITE; PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT

Model Number	3017SPI
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing batch record of the polysite 3017spi implantable port final product (lot 18070056) did not highlight any deviation that could be the root cause of the incident.Indeed, the sealing of the port-catheter-connection ring assembly is verified on 100% of the devices manufactured by injecting air at a pressure of 2.2 bar +/_ 0.2 bar for 1 minute.Alteration of the catheter or connecting ring would most likely have led to a leakage and would have been detected.The leak test performed on the 168 units manufactured is in accordance with the specifications.No deviations were detected.Unfortunately, in absence of the defective device, it was not possible to perform an investigation by the quality control lab.Regarding the phenomenon of separation of the catheter from the port, the most likely root cause would be an insufficient connection of the catheter to the port housing at the time of implantation.The catheter might not have been advanced enough on the titanium tube.Unfortunately, in the absence of the defective device and further clinical information (implantation/explantation reports and copy of x-ray), it was not possible to perform deep expertise of the incident in order to confirm this hypothesis.Perouse medical has not been informed of other incident involving the batch 18070056.Based on the potential root cause, no corrective action has been initiated.However, it was reminded that the different steps for the fixation of the catheter on the implantable port are precisely described in the instruction for use (ifu) of polysite implantable ports (section iv-c: port insertion procedure of polysite pressure injectable implantable infusion port - ifu # (b)(4)).(the package di is (b)(4)).Uf/importer report # (b)(6).
Event or Problem Description
According to the teleflex notification summary reference (b)(4) received on october 8th 2019: "the catheter dislodged from the port inside the patient.They had to use a snare to remove the catheter endovascularly and they revised the port another day." this incident took place in (b)(6).

• Brand Name: POLYSITE
• Common Device Name: PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT
• Manufacturer (Section D): PEROUSE MEDICAL; 60 173 ivry le temple; FR
• MDR Report Key: 9282069
• Report Number: 3004160911-2019-03043
• Device Sequence Number: 2524376
• Product Code: LJT
• UDI-Device Identifier: 03661234017584
• UDI-Public: 03661234017584
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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 Expiration Date: 06/30/2023
• Device Model Number: 3017SPI
• Device Lot Number: 18070056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention