MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN030150
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when introducing the guidewire, the guidewire looked split." the insertion site was the right femoral.The device was replaced and another attempt was successful.No patient harm was reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported that "when introducing the guidewire, the guidewire looked split." the insertion site was the right femoral.The device was replaced and another attempt was successful.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and 3-l catheter for analysis.The guide wire was advanced within the catheter.Definite signs of use were observed on the components.Visual examination revealed the guide wire is unraveled from the distal weld and is kinked/distorted in several locations along the body.The core wire distal j-bend was deformed and exposed out of the coil wire.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.Both welds were present and appeared full and spherical.Microscopic examination of the catheter did not reveal any defects or anomalies.The major kinks in the guide wire body measured 264mm and 355mm from the proximal tip.The broken core wire measured 680 mm in length, which is within the specification of 678-688 mm per guide wire product drawing; therefore no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.852 mm which is within the outer diameter specification of 0.838-0.877mm per guide wire product drawing.The catheter body length measured 217 mm which is within the specification of 207-227 mm per catheter product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit , which states "thread tip of multiple-lumen catheter over spring-wire guide.Sufficient guide wire length must remain exposed at hub end of catheter to maintain a firm grip on guide wire.Grasping near skin, advance catheter into vein with slight twisting motion".A lab inventory guide wire of the same diameter (0.877mm) was threaded through the catheter, and little to no resistance was encountered.Functional testing of the guide wire could not be performed due to the damage.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The ifu provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The customer report of an unraveled guide wire was confirmed by investigation of the returned sample.The guide wire and catheter passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Arrow guide wires 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 guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 16311586
• Report Number: 3006425876-2023-00108
• Device Sequence Number: 7049256
• Product Code: FOZ
• UDI-Device Identifier: 00801902102300
• UDI-Public: 00801902102300
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K900263
• 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): 01/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: IPN030150
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F21E0113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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