MAUDE Adverse Event Report: PFM MEDICAL CPP SA XCELA; POWER INJECTABLE PORT

Model Number H965451830

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

A thorough investigation was conducted to assess the potential causes of the complaint related to lot# 152094 of the xcela power injectable port with 9.6f x 500 mm attachable polyurethane catheter and silicone plugs product.The following steps were taken: device history record (dhr) review: final product: h965451830 lot# 152094.With components: port pom cp 08 violet assemble ref (b)(4), lot# 150255/150524/151989/152274.Catheter dual ref 61.000.10.442 lot # 151022.Click connector 4.0mm dual ref cli 31t lot #lt-22-0194.The records are complete and in order.The product meets its specification per inspections records.Review of recorded complaints: 2 other complaints with similar issue have been identified for broken pin on dual port: (b)(4): "the stem broke after the port was connected" (b)(4): "the stem of the dual lumen xcela port came off" total sales of ports (all references and all markets included) for 2010-2023: (b)(4).No trending identified (1 complaint in 2015, 1 complaint in 2019 and 1 complaint in 2023) review of ncr and capa: no ncr and or capa was identified related to similar issue.Review of risk analysis: verification of risk linked to dual pin breakage: in fmea file d-vas001 rev 10 risk d6: "catheter and port not safely connected" consequence: "leakage of medication.Tissue necrosis in case of cytostatic.Device explantation." risk d34: catheter not attached to stem securely consequence: "leakage of medication.Tissue necrosis in case of cytostatic.Device explantation." risk is identified in our risk analysis occurrence rate is below acceptable frequency of the risk analysis.Returned product verification: the port chamber has been returned alone without any other component (click, catheter, packaging).The lot number engrave on the port could be confirm as 152094 000.The defect could also be confirmed : the half part of the pin is broken at the base.Additional internal testing: regarding the reported issue, a verification has been made on internal product to try to reproduce the issue.The issue could only be reproduced by applying a lateral force with an engaged click.The half pin broke when reaching an angle near to 90° from pin axis.The test results suggest that a significant lateral force was applied during the connection of catheter-click to the dual port chamber.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 the product meets its specifications.The returned product investigation could confirm the defect.Additional investigation performed internally determined that the most probable cause of reported issue is a use error by applying a high lateral force on the pin (about 90° to the pin axis).The risk is identified in our risk analysis and occurrence's rate as per similar complaints review is below acceptable frequency of the risk analysis.Therefore, further additional action through capa is not required.

Event Description

An end user reported an issue with a xcela dual lumen plastic port.During a placement procedure, an audible snap was heard.The port was withdrawn and it was discovered that one of the attachment prongs had snapped off.The patient did not experience any adverse effects or harm as a result of this incident.

• Brand Name: XCELA
• Type of Device: POWER INJECTABLE PORT
• Manufacturer (Section D): PFM MEDICAL CPP SA; 9, allée du quartz; 2300 la chaux-de-fonds, switzerland ; SZ
• Manufacturer (Section G): PFM MEDICAL MEPRO GMBH; am soterberg 4; 6620 nonnweiler-otzenhausen, ; GM
• Manufacturer Contact: madison reid ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 18085767
• MDR Text Key: 328688389
• Report Number: 2032582-2023-00003
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00764014516320
• UDI-Public: 0764014516320
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2023

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
• Device Operator: Health Professional
• Device Model Number: H965451830
• Device Catalogue Number: H965451830
• Device Lot Number: 152094
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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): Other
• Patient Age: 29 YR
• Patient Sex: Male