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

Catalog Number	CV-15703-M
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Hematoma (1884); Needle Stick/Puncture (2462)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " during the installation of a central venous catheter in the continuous admission area on (b)(6) 2025, it was observed that during this procedure, when the guide was inserted, it bent during installation and became separated from its integrity." the patient was multiple punctured and had hematoma formation at the puncture site.The problem was resolved by placing new equipment.The previous central venous catheter was removed.A new catheter was placed.The patient's current condition is reported as "delicate".
Additional Manufacturer Narrative
(b)(4).The customer provided two photos and one video for analysis.The first image is of the cvc kit lidstock.The second photo is of a damaged guidewire inside a catheter during patient treatment.The video is of a clinician attempting to remove a guidewire from a catheter during patient treatment.The clinician seems to meet resistance when maneuvering the guidewire.The complaint of guidewire unraveled was able to be confirmed by customer provided images, however, a complete visual inspection to determine 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 , "warning: although the incidence of spring-wire guide failure is extremely low, practitioner should be aware of the potential for breakage if undue force is applied to the wire." the customer report of guidewire unraveled was confirmed by visual inspection of the customer supplied images/video.The images/video show the clinician having difficulty removing the guidewire and confirmed evidence of unraveling, however, full complaint verification testing to determine the cause of the damage could not be performed as no sample was returned for analysis.Arrow guidewires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guidewire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.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 " during the installation of a central venous catheter in the continuous admission area on (b)(6) 2025, it was observed that during this procedure, when the guide was inserted, it bent during installation and became separated from its integrity." the patient was multiple punctured and had hematoma formation at the puncture site.The problem was resolved by placing new equipment.The previous central venous catheter was removed.A new catheter was placed.The patient's current condition is reported as "delicate".

• 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 DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22852890
• Report Number: 9680794-2025-00704
• Device Sequence Number: 8457556
• Product Code: DQY
• UDI-Device Identifier: 00801902026408
• UDI-Public: (01)00801902026408(11)220524(17)270430(10)14F22D0319(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 07/29/2025

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
• Device Catalogue Number: CV-15703-M
• Device Lot Number: 14F22D0319
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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