MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Model Number	IPN918836
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	09/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2024, in the pediatric intensive care unit, the nurses noticed that a child's cvc was leaking under the skin after 4 days, causing discharge, redness and oedema." "the catheter was replaced and after removal, the surgeon found it to be blocked with a blood clot inside." it was further reported "there was clinical deterioration at the time of the incident linked to the poor administration of anti-infective therapy, but now i don't know if there are any long-term consequences of the incident.It's likely that the treatment solved all.".
Additional Manufacturer Narrative
(b)(4).The customer returned one cvc catheter for evaluation.Visual examination revealed obvious signs of use in the form of biological material on the catheter body.There was also a significant build up of biological material in the distal lumen.Microscopic examination of the distal lumen identified biological material fluid within distal lumen.Once manually pressurized by hand , the fluid flowed over the other particulate within the lumen which did not move.This indicated that there was some type of dried particulate or material (drugs, blood clot, etc.) within the lumen as well.The catheter body outer diameter measured 0.0565" , which is within the specification of 0.054"-0.058" per catheter body product drawing.The distal lumen inner diameter measured 0.055" which is within specification of 0.055"-0.059" per product drawing.The distal lumen outer diameter measured 0.0845" which is within specification of 0.084"-0.088" per product drawing.The ifu provided with this kit states "flush each lumen of catheter with sterile saline solution, to establish patency and prime lumen(s)." the returned catheter was flushed using a water-filled lab inventory syringe.No blockages or leaks were detected in the proximal lumen.When the distal lumen was attempted to be flushed, significant resistance was encountered.A lab inventory guidewire was inserted through the distal lumen and it encountered the significant build up of material that was within the lumen.The material was able to be successfully removed from the device.Microscopic examination of the removed blockage revealed that it was solid biological material that exited the lumen.Once the lumen had been cleared of the biological material, the catheter flushed as expected.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000071 rev.15) which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The device was connected to a lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.The extension lines were connected individually to the leak tester, and when pressurized, no catheter backflow or leaks were detected from any portion of the catheter, which indicates no inter-lumen crossover was observed.This testing confirmed that there were no functional defects with the catheter lumens.Clinical and medical affairs (cma) was consulted as part of this investigation.Cma stated, "intraluminal thrombosis can occur with cvc placement and can be a cause of failure.Complete ¿r partial occlusion ¿r difficulty infusing ¿r aspirating from the cvc may be associated with but is not necessarily a sign of cvc-related venous thr¿mbosi¿.Intraluminal precipitation of drugs ¿r minerals, blood products, ¿r kinking of the catheter from extraluminal causes can create this clinical picture or initiate the thrombosis pathway.Furthermore, formation of fibri tails or sheaths (thin, slender structures that wrap around the catheter or the distal end of the device) can also lead to catheter dysfunction." a device history record review was performed on the catheter with no relevant findings identified.The ifu provided with this kit warns the user, "clinicians must be aware of complications/undesirable side effects associated with central venous catheters including, but not limited to:.Thrombosis." "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the customer report of a catheter thrombosis was confirmed based on the sample investigation of the returned sample as well as clinical and medical affairs (cma) consultation.The device was returned with significant build up of biological material within the distal lumen.This build up obstructed attempts at flushing the catheter.Once the blockage was removed, the catheter was able to flush as expected.The device passed all relevant dimensional and functional inspection (after blockage removal).A device history record review was performed with no relevant findings to suggest a manufacturing related issue.Cma stated , "intraluminal thrombosis can occur with cvc placement and can be a cause of failure.Complete r partial occlusion r difficulty infusing ¿r aspirating from the cvc may be associated with but is not necessarily a sign of cvc-related venous thr mbos.Intraluminal precipitation of drugs r minerals, blood products, r kinking of the catheter from extraluminal causes can create this clinical picture or initiate the thrombosis pathway.Furthermore, formation of fibri tails or sheaths (thin, slender structures that wrap around the catheter or the distal end of the device) can also lead to catheter dysfunction.".Additionally, the ifu provided with this kit states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".Therefore, based on the available information, sample investigation, and input from cma, the root cause of this event cannot be determined.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2024, in the pediatric intensive care unit, the nurses noticed that a child's cvc was leaking under the skin after 4 days, causing discharge, redness and oedema." "the catheter was replaced and after removal, the surgeon found it to be blocked with a blood clot inside." it was further reported "there was clinical deterioration at the time of the incident linked to the poor administration of anti-infective therapy, but now i don't know if there are any long-term consequences of the incident.It's likely that the treatment solved all.".

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 5 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20491267
• Report Number: 3006425876-2024-01019
• Device Sequence Number: 14496625
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: (01)30801902124310(11)231030(17)280930(10)71F23K1555(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN918836
• Device Catalogue Number: CS-12402
• Device Lot Number: 71F23K1555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown