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 Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that " the guide wire was separate, out to be spring and stuck in vein of patient while the doctor insert guidewire to patient.Therefore, he had to opened new set of cs-12402 from stock in hospital.Only partial guidewire removed from the patient.The patient was not injured.".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The photos revealed a separation of the core wire and coil spring during use on the patient.Based on the photos as well as the additional information from the customer stating that not all of the guidewire was able to be removed from the patient, the complaint of guidewire separated was able to be confirmed, however, a complete visual inspection to evaluate the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns 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." based on the customer photos as well as the additional information from the customer stating that not all of the guidewire was able to be removed from the patient, the complaint of guidewire separated was able to be confirmed.However, full complaint verification testing to evaluate the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the guide wire was separate, out to be spring and stuck in vein of patient while the doctor insert guidewire to patient.Therefore, he had to opened new set from stock in hospital.Only partial guidewire removed from the patient.The patient was not injured." associated complaints 3006425876-2024-00835 and 3006425876-2024-00834.

• 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: 20093687
• Report Number: 3006425876-2024-00834
• Device Sequence Number: 15618813
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: (01)30801902124310(11)230711(17)280630(10)71F23G0012(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 08/01/2024

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 Catalogue Number: CS-12402
• Device Lot Number: 71F23G0012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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