MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15402-E
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "at the end of the insertion of the cvc, impossible to remove the swg despite flushing as indicated for this issue.Device is replaced." additional information received reports "no kinking of the guidewire or needle on insertion of the guidewire,but on the first attempt the catheter went jugular and not cardiac.So there was a partial remove of the guidewire to redirect it.There was observed a slight kink of the guidewire at this point.But there was no difficulty in redirecting the guidewire, but once positioned it was impossible to separate the needle from the guidewire." a new catheter was inserted without difficulty.There was no clnical consquences for the patient.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire advanced through a 21ga introducer needle and the product lidstock for analysis.Signs of use in the form of biological material were observed on and within the returned components.Visual analysis revealed multiple bends throughout the guide wire body.The distal j-bend was advanced past the needle bevel and kinking was observed on the j-bend.Microscopic examination confirmed the damage.Both welds appeared full and spherical.No other defects or anomalies were observed with the introducer needle.The guide wire was removed from the introducer needle and was observed to have three kinks on the body.Excess biological material was observed on the guide wire portion that was within the needle cannula.The distal j-bend was not misshapen and was intact.Both welds were present and were observed to be full and spherical.No defects or anomalies were observed on the introducer needle.The major kinks in the guide wire measured 12 mm 28 mm from the distal tip.The guide wire length measured 455 mm, which is within the specification limits of 449.2-458.8 mm per guide wire product drawing.The guide wire outer diameter measured 0.804 mm, which is within the specification limits of 0.432-0.457 mm per guide wire product drawing.The needle cannula outer diameter measured 0.0321", which is within the specification limits of 0.0320"-0.0325" per needle cannula product drawing.The inner diameter of the needle cannula measured 0.023", which is within the specification limits of 0.0225"-0.0240" per needle cannula product drawing.The guide wire and introducer needle were functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the returned guide wire was advanced through the returned introducer needle, and the undamaged portions of the guide wire advanced through with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.".The report of a guide wire/needle resistance with a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed that the guide wire met resistance due to a build-up of biological material inside the needle.The guide wire and needle met all relevant dimensional and functional requirements.A device history record review did not identify any manufacturing related issues.Based on these circumstances and the customer description, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "at the end of the insertion of the cvc, impossible to remove the swg despite flushing as indicated for this issue.Device is replaced." additional information received reports "no kinking of the guidewire or needle on insertion of the guidewire,but on the first attempt the catheter went jugular and not cardiac.So there was a partial remove of the guidewire to redirect it.There was observed a slight kink of the guidewire at this point.But there was no difficulty in redirecting the guidewire, but once positioned it was impossible to separate the needle from the guidewire." a new catheter was inserted without difficulty.There was no clinical consequences for the patient.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 8 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: 20558351
• Report Number: 3006425876-2024-01045
• Device Sequence Number: 8996573
• Product Code: DQY
• UDI-Device Identifier: 10801902099645
• UDI-Public: (01)10801902099645(11)230802(17)280731(10)71F23G0651(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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 Catalogue Number: CS-15402-E
• Device Lot Number: 71F23G0651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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 Age: 12 MO
• Patient Sex: Unknown