MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Codes	Material Disintegration (1177); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemothorax (1896); Pain (1994)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "during placement of a new central venous line, the patient developed a left hemothorax associated with hypovolemic shock due to a "defective device"." additional information received states "during the placement of a new central venous access, after asepsis and anesthesia, the area where the catheter will be inserted (left jugular vein) is visualized topically, the needle is inserted, and blood return is confirmed.After this, a metal guide is inserted, which passes without complications in a single attempt.After this, it is dilated with the dilator that comes with the device, and finally, the catheter is inserted, which had been tested and had return in the numbers.Once the return has been verified, the metal guide inside the catheter is removed, and resistance is evident at the moment of removal.When this occurs, the procedure guidelines suggest completely removing the devices to avoid any vascular compromise.It is then evident that from the tip of the catheter inward, which would be internally in the youngest, it was completely destroyed and disintegrated, so the device was removed in its entirety." further information provided states "after removing the device according to protocol, an image is taken and, above all, because the patient begins to show signs of hypovolemic shock, an x-ray image is taken showing hypoventilation, complete left- sided radiopacity, and, given the recent event, a diagnosis of hemothorax is made.Hemothorax drainage is performed, obtaining 10% of the youngest's blood volume.Thoracic surgery, vascular surgery, and pediatric surgeries are notified, and depending on the patient's progress, an examination will be considered.Blood products and medication were indicated and administered to monitor the patient (vitamin k), with improvement in the patient's condition.It was not necessary to take the patient to surgery, and in less than six hours, the hemothorax was resolved." the patient's current condition is unknown at this time.Associated mdr numbers include: 9680794-2025-00832 and 9680794- 2025-00883.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows a guide wire in a clinical setting partially advanced through the catheter and the guide wire was unraveled towards the distal end past the distal tip of the catheter.Based on the photo, the customer report of a damaged guidewire is confirmed, however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.Clinical and medical affairs (cma) was consulted and stated, "the reported guidewire fraying and subsequent vascular injury most likely resulted from user technique during device removal rather than a product defect.The guidewire appears to have experienced tensile overload and torsional stress consistent with forceful traction applied after encountering resistance.This pattern is typical of mechanical overstress that occurs when the wire is kinked or entrapped within the dilator or catheter and traction is continued rather than the entire assembly being removed together per standard technique.The resulting vascular injury and hemothorax are consistent with trauma from the frayed guidewire rather than any intrinsic defect in device materials or construction." 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." the customer report of guide wire unraveling was confirmed by visual inspection of the customer supplied photo.The image shows a guidewire partially advanced through a catheter in a clinical setting with 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.A device history record review was performed on the reported batch, and no relevant findings were identified to suggest a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Cma has suggested the guidewire failure represents a use error during removal that caused mechanical damage and vascular injury; however, 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 "during placement of a new central venous line, the patient developed a left hemothorax associated with hypovolemic shock due to a "defective device"." additional information received states "during the placement of a new central venous access, after asepsis and anesthesia, the area where the catheter will be inserted (left jugular vein) is visualized topically, the needle is inserted, and blood return is confirmed.After this, a metal guide is inserted, which passes without complications in a single attempt.After this, it is dilated with the dilator that comes with the device, and finally, the catheter is inserted, which had been tested and had return in the numbers.Once the return has been verified, the metal guide inside the catheter is removed, and resistance is evident at the moment of removal.When this occurs, the procedure guidelines suggest completely removing the devices to avoid any vascular compromise.It is then evident that from the tip of the catheter inward, which would be internally in the youngest, it was completely destroyed and disintegrated, so the device was removed in its entirety." further information provided states "after removing the device according to protocol, an image is taken and, above all, because the patient begins to show signs of hypovolemic shock, an x-ray image is taken showing hypoventilation, complete left- sided radiopacity, and, given the recent event, a diagnosis of hemothorax is made.Hemothorax drainage is performed, obtaining 10% of the youngest's blood volume.Thoracic surgery, vascular surgery, and pediatric surgery are notified, and depending on the patient's progress, an examination will be considered.Blood products and medication were indicated and administered to monitor the patient (vitamin k), with improvement in the patient's condition.It was not necessary to take the patient to surgery, and in less than six hours, the hemothorax was resolved." the patient's current condition is unknown at this time.Associated mdr numbers include: 9680794-2025-00832 and 9680794- 2025-00883.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 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: 23277662
• Report Number: 9680794-2025-00832
• Device Sequence Number: 12975455
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)230718(17)271130(10)14F23G0103(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 09/17/2025

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
• Device Catalogue Number: CS-14402
• Device Lot Number: 14F23G0103
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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 REPROTED.; NOT REPROTED.
• Patient Age: 5 YR
• Patient Sex: Unknown