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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In absence of the defective device and the batch number, it was not possible to perform: a review of the batch record; a deeper expertise of the defect by the quality control lab.Consequently, the root cause of this complaint could not been precisely determined.According to the information received: the device was implanted on (b)(6) 2018 and the incident was observed on (b)(6) 2018, more than months after implantation.Regarding the phenomenon of separation of the catheter from the port, the most likely root cause would be a bad connection of the catheter at the time of the implantation.Unfortunately, the following information (venous access routes, implantation report, copy x-ray implantation, copy xray event) are not available in the notification summary transmitted by the fda.No additional information has been provided to us.So it is not possible to confirm this hypothesis and to precisely identify the origin of the incident reported.No similar incident has been recorded for polysite reference 3017spi.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 implantable ports (section iv-c: port insertion procedure of polysite pressure injectable implantable infusion port - ifu# cd00632_001).Other remarks: lot #, serial #, udi #: because the batch number and serial number are unknown, the complete udi is not available.Only the primary di has been documented (the package di is (b)(4)).
Event or Problem Description
According to the medwatch (mw5081802): "upon removal of mediport it was noted that the connector was not attached to the port itself.Fluoroscopy was used to determine where or if connector was still in the patient.Blunt dissection was utilized to retrieve connector with hemostats.No danger to patient was noted and no post procedure complication was noted".This information has been received from the distributor (b)(4) on 02 jan 2019 at perouse medical.

• Brand Name: POLYSITE
• Common Device Name: PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT
• Manufacturer (Section D): PEROUSE MEDICAL; ivry-le-temple, 60173 ; FR 60173
• MDR Report Key: 8600372
• Report Number: 3006942524-2019-00001
• Device Sequence Number: 11265416
• Product Code: LJT
• UDI-Device Identifier: 03661234017584
• UDI-Public: 03661234017584
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K122834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 05/10/2019
• 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