MAUDE Adverse Event Report: PFM MEDICAL CPP SA TITA JET LIGHT LOW PROFILE; PORT

Model Number 61.636.09.077-ARM SIMILAR TO 611.360.9078-HA

Device Problems Use of Incorrect Control/Treatment Settings (1126); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

Device similar to one marketed in the united states.Review of device history records: the records are complete and in order.The product meets its specification per inspections records.Manufacturing date: 08/31/2020 expiration date: 09/20/2025.Review of recorded complaints on the last three years (2019-2021): no complaint recorded for lot# 147724.3 complaints identified with similar issue (catheter disconnection).Total sales of vas (all references and markets included) for 2019-2021: 185'000.Complaint rate of (b)(4) of the sales.Review of risk analysis: risk is identified in our risk analysis, occurrence's rate is below acceptable frequency of the risk analysis, potential occurrence's rate of <0.005%.Conclusion: the manufacturer conducted a documentary and returned product investigation into the reported problem with complete dhr, testing data and product review.This review demonstrates that product meets its specifications.Disconnection verification made during production and validation of the design ensure that there is no risk linked to the product.The most probable root cause is a use error as the product is required to be use at maximum 3ml/s or 300psi with an injected media with a viscosity at 6.1 cp.As describe in the complaint, omnipaque 350 has been used with a viscosity at 37°c to 10.6 mpa.S with a needle 20g smaller than the tested 19g that increase pressure in the device and after having been used above the recommended maximum pressure to 3 ml/s indicate in the ifu.The risk of disconnection is identified in our risk analysis and occurrence's rate is lower than established frequency of the risk analysis.Therefore, further action through capa management at pfm medical cpp sa is not required.We sincerely apologize for any difficulty or inconvenience that may have occurred.To ensure an optimal management of a complaint, the return of the product concerned is crucial for a complete investigation.Pfm medical cpp will continue monitoring for additional occurrences of this type of incident.

Event Description

Reported defect (device similar to one sold in the usa): there have previously been 2 port disconnection incidents, which have required interventional radiology and surgical intervention to retrieve the port catheter at the royal marsden hospital.Both had the same lot no 147724000.This port was inserted on the 28/09/2021 for the patient's intravenous chemotherapy regimen and ct contrast to be administered through.The patient had previously had her port used for ct contrast three times before without incident.On one occassion a flow rate of 3.5 mls was used as an arterial liver scan was required on the (b)(6) 2022.The other three occasions including this time when the incident occurred on the (b)(6) 2022, a flow rate of 2 mls per second were used.The patients port had also been used twice in mri with a pump at a flow rate of 2 ml - again with a psi of 300 set.When the disconnection of the catheter occurred, the patients pport had been accessed using a 20g 19mm ez huber needle with good blood return on accessing.The routine in ct is to hand inject with saline before connecting to the power pump, which was done.The patient was informed to let ct staff know if there is any pain on power injection which the patient did, the injection was then stopped.On both occassions when the disconnection occurred during ct scanning, a humerus x-ray was taken which showed the disconnection of the catheter from the port.In both cases when the port was found to be disconnected, omnipaque 350 was used for the ct scanning.".

Event Description

Reported defect (device similar to one sold in the usa): there have previously been 2 port disconnection incidents, which have required interventional radiology and surgical intervention to retrieve the port catheter at the (b)(6) hospital.Both had the same lot no 147724000.This port was inserted on the (b)(6) 2021 for the patient's intravenous chemotherapy regimen and ct contrast to be administered through.The patient had previously had her port used for ct contrast three times before without incident.On one occassion a flow rate of 3.5 mls was used as an arterial liver scan was required on the 14/07/2022.The other three occasions including this time when the incident occurred on the 14/10/2022, a flow rate of 2 mls per second were used.The patients port had also been used twice in mri with a pump at a flow rate of 2 ml - again with a psi of 300 set.When the disconnection of the catheter occurred, the patients pport had been accessed using a 20g 19mm ez huber needle with good blood return on accessing.The routine in ct is to hand inject with saline before connecting to the power pump, which was done.The patient was informed to let ct staff know if there is any pain on power injection which the patient did, the injection was then stopped.On both occassions when the disconnection occurred during ct scanning, a humerus x-ray was taken which showed the disconnection of the catheter from the port.In both cases when the port was found to be disconnected, omnipaque 350 was used for the ct scanning.".

Manufacturer Narrative

Device similar to one marketed in the united states.Review of device history records: the records are complete and in order.The product meets its specification per inspections records.Manufacturing date: 08/31/2020.Expiration date: 09/20/2025.Review of recorded complaints on the last three years (2019-2021): no complaint recorded for lot# 147724.3 complaints identified with similar issue (catheter disconnection).Total sales of vas (all references and markets included) for 2019-2021: 185'000.Complaint rate of = (b)(4) of the sales.Review of risk analysis: risk is identified in our risk analysis.Occurrence's rate is below acceptable frequency of the risk analysis.Potential occurrence's rate of (b)(4).Conclusion: the manufacturer conducted a documentary and returned product investigation into the reported problem with complete dhr, testing data and product review.This review demonstrates that product meets its specifications.Disconnection verification made during production and validation of the design ensure that there is no risk linked to the product.The most probable root cause is a use error as the product is required to be use at maximum 3ml/s or 300psi with an injected media with a viscosity at 6.1 cp.As describe in the complaint, omnipaque 350 has been used with a viscosity at 37°c to 10.6 mpa.S with a needle 20g smaller than the tested 19g that increase pressure in the device and after having been used above the recommended maximum pressure to 3 ml/s indicate in the ifu.The risk of disconnection is identified in our risk analysis and occurrence's rate is lower than established frequency of the risk analysis.Therefore, further action through capa management at pfm medical cpp sa is not required.We sincerely apologize for any difficulty or inconvenience that may have occurred.To ensure an optimal management of a complaint, the return of the product concerned is crucial for a complete investigation.Pfm medical cpp will continue monitoring for additional occurrences of this type of incident.

• Brand Name: TITA JET LIGHT LOW PROFILE
• Type of Device: PORT
• Manufacturer (Section D): PFM MEDICAL CPP SA; 9, alle du quartz; 2300 la chaux-de-fonds, ; SZ
• Manufacturer (Section G): PFM MEDICAL CPP SA; 9, allee du quartz; 2300 la chaux-de-fonds, ; SZ
• Manufacturer Contact: troy taylor ; 1916 palomar oaks; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 15905443
• MDR Text Key: 308146967
• Report Number: 2032582-2022-00008
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 61.636.09.077-ARM SIMILAR TO 611.360.9078-HA
• Device Catalogue Number: 61.636.09.077-ARM SIMILAR TO 6
• Device Lot Number: 147724
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female