MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15703
Medical Device Problem Codes	Material Twisted/Bent (2981); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for evaluation.The photos showed the product lidstock and additional notes describing the reported defect.The complaint of a defective guide wire could not be confirmed by the photos.The guide wire module requirement document ((b)(4) rev 04) was reviewed as part of this complaint investigation.It states that "a swg is typically composed of a coil wire wrapped around a solid core wire.The coil forms the device's outside diameter and provides swg flexibility.The core wire gives column strength and rigidity to the swg, with either one or both ends ground to form an end that is more flexible than the body of the wire." therefore, the guide wire is designed to enable greater flexibility of the ends during use.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this 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 ifu also states, "precaution: maintain firm grip on guidewire at all times.Keep sufficient guidewire length exposed for handling purposes.A non-controlled guidewire can lead to wire embolus." without the device to evaluate , the complaint could not be confirmed , and 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 "the wire of the product is very light and cannot be controlled (moves in wrong directions) during insertion into the artery." additional information reports, "the guidewire is easily kinking during the insertion." the user changed to a new set.The patient's current condition is reported as "unknown".Additional information was requested from the customer; however, further details have not been provided at this time.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20629523
• Report Number: 3006425876-2024-01051
• Device Sequence Number: 15287999
• Product Code: DQY
• UDI-Device Identifier: 30801902125959
• UDI-Public: (01)30801902125959(11)230926(17)280131(10)71F23J1044(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2024

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-15703
• Device Lot Number: 71F23J1044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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
• Patient Sex: Unknown