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

Model Number	4018SPI
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of manufacturing batch record of the polysite 4018spi implantable port final product (lot 16050489) did not highlight any deviation that could be the root cause of he 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 (b)(4) units manufactured is in accordance with the specifications.No deviation was detected.The device has not been returned to perouse medical.Unfortunately , in absence of the defective device, it was not possible to perform an investigation by the quality control lab.According to the information received from the fda, the separation of the catheter from the port was detected 5 days after implantation, the most probable root cause would be a bad connection of the catheter at the time of implantation.However, in the absence of additional information, it is not possible to confirm this hypothesis and to precisely identify the origin of the incident reported.Consequently, the root cause of this complaint could not been precisely determined.Perouse medical has not been informed of other similar incident involving the batch 16050489.Furthermore, the different steps for the fixation of the catheter on the implantable port are precisely described in the instruction for use (ifu) of polysite ports (section iv-c: port insertion procedure of polysite pressure injectable implantable infusion port - ifu# cd00632_001 and section iv-c: port insertion procedure of polysite implantable infusion port - ifu # cd00640/002).Only the primary di number has been documented.The package di number (b)(4).Uf/importer report # (b)(4) / mw5089175.
Event or Problem Description
According to the medwatch mw5089175 received on september 10th 2019: "implantable infusion port placed in (b)(6) 2019; placement was confirmed by imaging and patency establish.An attempt to access the port at an outside facility was reported to be unsuccessful; images showed the catheter and port were separated.The device was removed and replaced on (b)(6) 2019.".

• 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: 9176841
• Report Number: 3004160911-2019-02438
• Device Sequence Number: 13555498
• Product Code: LJT
• UDI-Device Identifier: 03661234017621
• UDI-Public: 03661234017621
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 06/30/2021
• Device Model Number: 4018SPI
• Device Lot Number: 16050489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/10/2019
• 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