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

Model Number	3017SPI
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Port 3017spi placed on (b)(6) 2022.On (b)(6) 2022, facility was unable to do a blood draw.Under scan, facility noticed that the catheter had "detached" from the port.Doctor used a snare to retrieve the catheter and removed the port.Under evaluation, it was stated the catheter did not look punctured, and rather that it just detached.Patient is going to receive a picc line insted of a port going forward.
Additional Manufacturer Narrative
The review of the manufacturing batch record of the polysite 3017isp implantable port final product (lot 20100154) 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 179 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, the separation of the catheter from the port was detected 4 weeks after implantation.Regarding the phenomenon of separation of the catheter from the port only 4 weeks 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 hasn't been informed of other incidents implying the batch 20100154.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® - ifu # cd00632_003).

• Brand Name: POLYSITE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): PEROUSE MEDICAL; 4 rue saint-anne; ivry le temple, 60173 ; FR 60173
• Manufacturer Contact: agnès jordan ; 4 rue saint-anne; ivry le temple, 60173 ; FR 60173
• MDR Report Key: 15548088
• Report Number: 3006942524-2022-01309
• Device Sequence Number: 13929516
• Product Code: LJT
• UDI-Device Identifier: 03661234017584
• UDI-Public: 03661234017584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/05/2022

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: 3017SPI
• Device Lot Number: 20100154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown