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

Model Number H965451110

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Discoloration (2074)

Event Date 01/14/2024

Event Type  malfunction  

Manufacturer Narrative

Review of device history records for (b)(6) lot# 153909000: ->batch records is complete.No deviation was identified during manufacturing.->recorded disconnection force of catheter from port: 21.30n (above requirement of min >10n for pur catheter per inc 7030).The product meets its specification per manufacturing records.Review of nc and capa ->no nc and or capa was identified related to similar issue on product (b)(6) or lot#153909000.Return product verification ->the defective material was received in a carton box containing individual closed zip-lock bags identified with their own complaint: returned material from complaint (b)(4) (our internal reference (b)(4)) returned material from complaint (b)(4) (this complaint (b)(4)) bag (b)(4) was opened and material extracted: lot# 153909000 confirmed: a visual inspection of the returned material identified few marks potentially due to grabbing instruments and discoloration.No trace of puncture on the septum nor on suture hole plugs could be immediately observed.->the returned device was received with a section of catheter still connected to the port, including its click connector being in place.The review immediately identified that the catheter was connected the wrong way: the 5cm mark is next to the connection of the port: the finished goods (b)(6) (as reported herein) is not delivered in a pre-connected configuration.Consequently, if the catheter is connected as per ifu, a greater distance mark shall be visible near to the connection of the port.Per design, the 5cm mark is located at the distal end of the catheter, which is tapered.As instructed in the product ifu, the tapered end (distal end) is intended to be inserted first into the patient's vein to avoid potential damage due to catheter insertion.It can be determined the catheter connection was not performed as per ifu.- examination under microscope of the suture hole plugs indicates that none of them was used for the suturing of the port chamber: no trace of puncture with a suturing needle could be observed.It is then an assumption that the port was not sutured while in place, causing a potential flip of the device and preventing from properly palpating and locating the septum of the port.A counter testing with a huber needle through similar standard plugged titanium port shows that, even using a huber needle, the instrument leaves a trace in the silicone.A suture needle being a plain rod of metal, there shall be a trace left in the silicone.- examination of the septum, under microscope, after herein flushing testing, revealed the septum was punctured twice: ->puncture#1: there is a high likelihood this was done during the initial preparation/implantation of the device ->puncture#2: generated by the investigator for the sake of flushing testing port testing: with 10 ml syringe and a straight huber needle (b)(6) lot# lt-23-0327 from internal inventories was tested for water aspiration and injection before performing the test.The returned port chamber was punctured once and injected with 10ml of tap water above the glass of water with no issue.The tap water could circulate flawlessly, with no leak (from septum nor connection) through the returned device, confirming the port chamber is not blocked nor leaking: conclusion of investigation: -> the reported issue [?]port had leaked' is not confirmed, the port could be flushed with no effort and no leak was observed.-> a leak might happen due to the improper catheter connection.It is an assumption only as, testing under high pressure could not be performed due to product contamination -> no trace of puncture in the plugs of suture holes was observed, potentially indicating the port was not sutured in place as indicated in the ifu.No suturing of the device might cause a [?]port flip', preventing from locating properly the septum prior to puncture.-> the most probable root cause of medication leak is the mis puncture of the port, generating an administration of medication outside the port, explaining the reported necrosis.Based upon the above, this complaint is classified as unjustified/ use error: mispuncture.Review of recorded similar complaints: 2014-2024."leak/mispuncture": (b)(4) complaints.Complaint rate based on marketing sales: (b)(6) 2014 - (b)(6) 2024: all markets: (b)(4) ports.->complaints' rate (b)(4).Review of risk analysis: file d - (b)(4) rev 10: -"leak" due to user risks "device implantation", "use error" (incorrect connection of the catheter, catheter damage, mispuncture, use of coring needle) consequence: necrosis, inflammation, tissue damages, patient discomfort defined potential occurrence rate: (b)(4).-> complaints' rate (b)(4) is below the threshold.-> risk is identified in our risks analysis & occurrence's rate below defined acceptable frequency of the risk analysis.Conclusion: the manufacturer conducted a documentary review and returned product investigation.Product meets its specifications per documentary review.Reported defect could not be reproduced during returned product technical investigation.When product material defect excluded, most probable cause of leak is mis-puncture.Therefore, complaint is classified as unjustified / use error: mis-puncture.The related risk is identified in our risks analysis and occurrence's rate below defined acceptable frequency.Therefore, no further action is required.

Event Description

A risk management analyst reported an issue with an angiodynamics port.On (b)(6) 2024, the patient had a drain and port placed after receiving a stage 4 breast cancer diagnosis.The patient had 'multiple pleuros' and vesicant was administered.On (b)(6) 2024, the patient was evaluated due to a "change in their skin," when it was discovered that the port had leaked, resulting in necrotic tissue from the vesicant.Patient was administered regitine to treat the necrosis.An x-ray was performed, prior to removal, to confirm correct port placement which was confirmed.The patient was reported as 'stable' but did have a wound vac placed following removal of the port.

• 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: 18763237
• MDR Text Key: 337073413
• Report Number: 3008737795-2024-00002
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073210
• 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: 02/22/2024

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
• Device Operator: Health Professional
• Device Model Number: H965451110
• Device Catalogue Number: H965451110
• Device Lot Number: 153909
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2023
• 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