MAUDE Adverse Event Report: PFM MEDICAL CPP SA XCELA; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number H965451840

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Extravasation (1842); Easy Bruising (4558)

Event Date 05/17/2022

Event Type  malfunction  

Event Description

Port was placed in four years ago from cath lab vascular surgery from another facility.Last appointment with infusion nurses, they were unable to draw blood and instead saw some swelling in the area.Port removed in the outpatient setting noting it was broken (cut) about an inch from the port.Device information from the chart: port power injectable xcela dual lumen plastic 9.6 pre-attac port power injectable xcela dual lumen plastic 9.6 pre-attac navilyst_medical_inc.What was the original intended procedure? : blood draw.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working) ;.

Manufacturer Narrative

Dhr review: the device history record was performed and no deviations were found.No non-conformance record associated with lot#141399 that could have contributed to the complaint.Review of recorded complaints on the last three years (2019-2022): no complaint recorded for lot#141399.No similar issue identified on dual port.(b)(4.Review of risk analysis: risk is identified within the risk analysis.Potential occurrence's rate of (b)(4).Occurrence's rate is below acceptable frequency of the risk analysis.Return product investigation: 1 port have been received in a bio-hazard packaging.No external product packaging or label were available.A visual inspection has been performed.It clearly appears that one of the two channels of the catheter has "burst'' at about 2cm from the click end.Functional testing verification: a flushing test has been performed with water on each chamber of the port.Chamber 1 (with the "t" at the back) is blocked.Chamber 2 (with the "c" at the back), side of the "bursted" catheter has been rinsed easily without applying excessive pressure and water came out through both end of catheter end burst.Potential root causes: lack of rinsing or error in rinsing procedure for the port blockage causing blood clot pinch-off causing catheter rupture due to implantation too close of clavicle too high pressure injection causing burst channel connected to chamber 2, especially if used despite blood clot conclusion: device history records review demonstrates that product meets its specifications.The investigation of the return product port concludes that the port is obstructed by blood residues and that the catheter burst at about 2 cm if the pin.The risk is identified in our risk analysis and occurrence rate and similar complaints review is below the threshold frequency of the risk analysis.

• Brand Name: XCELA
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): PFM MEDICAL CPP SA; 9, allee 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: 14789684
• MDR Text Key: 303249128
• Report Number: 2032582-2022-00003
• Device Sequence Number: 1
• Product Code: LJT
• 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: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: H965451840
• Device Catalogue Number: H965451840
• Device Lot Number: 141399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• 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