MAUDE Adverse Event Report: ST PAUL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	KIT, POWER PAC II, VEN, PU, 2.6MM, UL 1/EA
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292); Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical implantable ports|deltec power port-a-cath ii ports was observed leaking around distal connection to port.A new device was inserted on patient.No patient adverse events reported.
Additional Manufacturer Narrative
Investigation completed on a smtihs medical implantable ports| deltec power port-a-cath ll ports.When visually inspecting device under normal lighting from a distance of 12" to 16" revealed a fissure detected on the catheter close to port.Mitigation revealed on other lots that the port a cath passed 100 % on inspections prior to release.The root cause was believed the incident of crack occurred after leaving manufacture.Complaint could not be verified as damage was believed to occur after manufacturing process.Due to previous complaints quality engineer on (b)(6) 2020 was made aware of complaint.Updated fields.A 1, b 1, b 3, b 4, b 5, d 10, g 7, h 1, h 2, h 3, h 6, h 10.
Event or Problem Description
Investigation completed on a smiths medical implantable ports|deltec power port-a-cath ii ports.Device evaluation in h 10.
Additional Manufacturer Narrative
Visual inspection of the returned sample identified a fissure on the catheter close to the port.Based on manufacturing controls, it was improbable that this type of damage originated during the manufacturing process.The most probable cause was that damage occurred after the product left the manufacturing facility.The instructions for use (ifu) warns the user of the following failure to suture the portal in place or tunnel the catheter to the portal when appropriate, may cause catheter flexing which could result in catheter occlusion or catheter fragmentation, fracture or shearing.Do not withdraw blood from or infuse medication into any area of the arm where the system is located unless you are using the portal.Do not measure the patient's blood pressure on this arm.Failure to observe these restrictions could cause inadvertent catheter puncture, catheter occlusion, or other catheter damage.Avoid medial catheter placement into the subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing or fragmentation due to compression of the catheter between the first rib and clavicle.Do not use any instruments to assist in seating the connector, do not use forceps or instruments with teeth or sharp edges to attach the catheter to the portal, as this may damage the catheter and could result in embolization of all or part of the catheter in system leakage.For non-power injection applications, do not exceed a pressure of 40 pounds per square inch (psi) when flushing through the system.Damage due to excessive pressure may include, but is not limited to, catheter rupture or fragmentation with possible embolization, or drug extravasation.The root cause of this failure was unable to be determined.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; parque industrial internaciona; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442 ; 3833310
• MDR Report Key: 9941141
• Report Number: 3012307300-2020-02772
• Device Sequence Number: 11618807
• Product Code: LJT
• UDI-Device Identifier: 10610586032790
• UDI-Public: 10610586032790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2022

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 Expiration Date: 04/15/2024
• Device Model Number: KIT, POWER PAC II, VEN, PU, 2.6MM, UL 1/EA
• Device Catalogue Number: 21-4485-24
• Device Lot Number: 3772620
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 07/05/2022
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 08/25/2020; 09/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown