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

Catalog Number	CS-12402
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during insertion, the doctor found the swg unravelled during used on the patient.The catheter 5cm side hole was found block during used on the patient.".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.The associated emdr report numbers are 3006425876-2025-00242.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided one image for analysis.The image shows an unraveled guidewire being held in a glove.The customer complaint of an unraveled swg during use was confirmed by the customer-provided image.The customer also returned one catheter for evaluation.The guidewire was not returned.Visual examination of the catheter revealed obvious signs of use in the form of biological material.No other defects or anomalies were observed with the catheter.Visual analysis of the guidewire could not be completed since it was not returned.Dimensional analysis of the guidewire could not be performed as it was not returned for analysis.The overall length of the catheter body measured 2 1/16", which is within the specification limits of 1 25/32" - 2 3/16" per the catheter product drawing.The distal extension line outer diameter measured 0.08581", which is within the specification limits of 0.084" - 0.088" per the distal extension line extrusion product drawing.The distal extension line inner diameter measured 0.05650", which is within the specification limits of 0.055" - 0.059" per the distal extension line extrusion product drawing.The proximal extension line outer diameter measured 0.0865", which is within the specification limits of 0.084" - 0.088" per the proximal extension line extrusion product drawing.The proximal extension line inner diameter measured 0.0571", which is within the specification limits of 0.055" - 0.059" per the proximal extension line extrusion product drawing.Functional inspection could not be performed as the guidewire was not returned for analysis.A device history record review was performed and no relevant manufacturing issues were identified.The ifu provided with this kit informs the user, "warning: do not apply excessive force in removing guide wire, dilator, or sheath." the report of an unraveled guidewire was confirmed through visual analysis of the customer-provided image, however, the guidewire was not returned as part of this complaint investigation.The customer only returned one catheter.Visual analysis of the catheter did not reveal any defects or anomalies.Additionally, the catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and without the guidewire returned, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during insertion, the doctor found the swg unravelled during used on the patient.The catheter 5cm side hole was found block during used on the patient." they changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.The associated emdr report numbers are 3006425876-2025-00243 and 3006425876-2025-00242.

• 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: 21558723
• Report Number: 3006425876-2025-00243
• Device Sequence Number: 4430878
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: (01)30801902124310(11)231005(17)280930(10)71F23J1322(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): 02/20/2025

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: CS-12402
• Device Lot Number: 71F23J1322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown