MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found the swg/ars resistance during used on the patient when the swg inserted into the ars.They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#: (b)(4).The customer returned one, opened cvc kit including one guide wire within its assembly, an arrow raulerson syringe (ars), and an 18ga introducer needle for analysis.Signs of use were observed on and within the returned components.Visual inspection of the guide wire revealed a kink towards the distal end.The distal j-bend was slightly misshapen.Microscopic examination confirmed the damage.Both welds were present and appeared to be full and spherical.Visual inspection of the ars revealed no obvious defects or anomalies.The kink on the guide wire measured 569 mm from the proximal end.The guide wire total length measured 602 mm, which is within the specification limits of 596-604 mm.Per guide wire product drawing.The guide wire outer diameter measured 0.791 mm, which is within the specification limits of 0.788-0.826 mm per guide wire product drawing.Functional inspection of the guide wire was performed per the product instructions for use (ifu) which states , "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was inserted through the returned ars and 18ga introducer needle and advanced with little to no resistance.A manual tug test confirmed the distal and proximal welds were intact.A device history record review was performed, and one potential finding was identified.A non-conformance was initiated for lot 71c22h0825 to address the issue of ars damaged/defective.The failure mode of this complaint is not the same as/relevant to the non-conformance identified.The non-conformance addresses the syringe handle separating from the plunger body.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage.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 kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed one kink towards the distal end of the guide wire.Despite this, the guide wire and ars met all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "the doctor found the swg/ars resistance during used on the patient when the swg inserted into the ars.They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required".

• Brand Name: ARROW CVC SET: 5 FR X 20 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: 21149466
• Report Number: 3006425876-2025-00096
• Device Sequence Number: 9117939
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)220829(17)270731(10)71F22H3582(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F22H3582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown