MAUDE Adverse Event Report: PEROUSE MEDICAL POLYSITE; POLYSITE PRESSURE INJECTABLE INFUSION PORT WITH SILICONE-FILLED SUTURE

Model Number	3017SPI
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Expulsion (2933)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The malfunctioning devices will be returned to the manufacturer and upon receipt, an investigation will be conducted.Fda will be notified of the results upon completion of this investigation.
Event or Problem Description
Port eroding through the skin.Port was removed.
Additional Manufacturer Narrative
Correction: the date of the event should be april 29, 2024, not may 30, 2024.The previous initial report listed may 30, 2024.Erroneously, there were two occurrences within this complaint.Those occurrences were captured in the following mdrs: mdr 2245270-2024-00047.Mdr 2245270-2024-00048.The review of the manufacturing batch records of the polysite 3017spi implantable port final product (batch 23040046 and batch 22050001) did not highlight any deviation that could be the root cause of the incident.The results of the tests carried out on the two returned devices did not reveal any defect that could have caused the problem described in this complaint "port eroding through the skin".There was no further information provided by the hospital regarding this complaint "port eroding through the skin".The most likely hypothesis that could explain the externalisation phenomenon from the implantable port could be: - the use of an implantable port not adapted to the patient's morphology (dimension (too large), material, indication,.), - an implantable port located less than 1 cm from the skin, - weight loss of the patient, - the weakening of the patient's skin by chemo products.Unfortunately, without additional information and regarding our investigation, it is not possible to confirm these hypothesis.Perouse medical has not been informed of another incident involving lot 23040046.Perouse medical has not been informed of another incident involving lot 22050001.In conclusion and according to the investigation performed, the root cause of this complaint could not be precisely determined.
Event or Problem Description
Port eroding through the skin.Port was removed.Pt will require new access.

• Brand Name: POLYSITE
• Common Device Name: POLYSITE PRESSURE INJECTABLE INFUSION PORT WITH SILICONE-FILLED SUTURE
• Manufacturer (Section D): PEROUSE MEDICAL; route du manoir; ivry, le temple 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: 19462175
• Report Number: 2245270-2024-00048
• Device Sequence Number: 6653077
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: 3017SPI
• Device Lot Number: 22050001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown