MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN918768
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "according to the report received from the hospital department, during a venous catheterization and stenting procedure, a complication occurred while withdrawing the guidewire.The guidewire became stuck, and upon removal, the internal metallic strand of the wire detached and pierced the operator's finger." the device was removed and replaced.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn (b)(4).
Additional Manufacturer Narrative
(b)(4) complaint verification testing 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, "precaution: if resistance is encountered when attempting to remove guidewire after catheter placement, guidewire may be kinked around tip of catheter within vessel.In this circumstance, pulling back on guidewire may result in undue force being applied resulting in guidewire breakage.If resistance is encountered, withdraw catheter relative to guidewire about 2-3 cm and attempt to remove guidewire.If resistance is again encountered, remove guidewire and catheter simultaneously." 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 "according to the report received from the hospital department, during a venous catheterization and stenting procedure, a complication occurred while withdrawing the guidewire.The guidewire became stuck, and upon removal, the internal metallic strand of the wire detached and pierced the operator's finger." the device was removed and replaced.There was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22205474
• Report Number: 3006425876-2025-00535
• Device Sequence Number: 15175467
• Product Code: DQY
• UDI-Device Identifier: 10801902105407
• UDI-Public: (01)10801902105407(11)240925(17)281231(10)71F24J0973(21)
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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,Followup
• Report Date (Section B): 05/23/2025

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 Model Number: IPN918768
• Device Catalogue Number: CV-16702
• Device Lot Number: 71F24J0973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2024
• 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