MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAP

Catalog Number	CDA-45703-P1A
Medical Device Problem Codes	Unraveled Material (1664); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the guide did not fit with the catheter" during use.A new product was used.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the guide did not fit with the catheter" during use.A new product was used.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4), the customer provided four images of the damage.The images show the product lidstock and components within the kit, including one guide wire assembly and catheter.The customer returned one opened cvc kit, including one guide wire assembly and catheter, for analysis.Definite signs of use were observed on the returned components.Visual analysis revealed that the guide wire was unraveled from the proximal weld and one major kink was observed.The returned catheter and insertion components (ars and needle) show evidence of use but no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The distal j-bend was misshapen but intact.Both welds were present and appeared full and spherical.Microscopic examination of the catheter and insertion components did not reveal any defects or anomalies.The major kink in the guide wire body were measured at 351mm from the proximal tip.The broken core wire measured 600 mm in length, which is within the specification of 596mm - 604mm mm per guide wire product drawing; therefore no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured 0.79mm which is within the outer diameter specification of 0.788mm - 0.826mm per guide wire product drawing.The catheter body length measured 215mm which is within the specification of 207mm - 227mm per catheter product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." a lab inventory guide wire was threaded through the catheter with little to no resistance.Functional testing of the guide wire could not be performed due to the damage.A manual tug test confirmed that the distal weld was secure and intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (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 report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guide wire and catheter met all functional and dimensional requirements during investigation testing.No manufacturing defects were found during this investigation and a lab inventory guide wire was threaded through the catheter with little to no resistance.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 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.Based on these circumstances, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• 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: 17492325
• Report Number: 9680794-2023-00561
• Device Sequence Number: 7872187
• Product Code: FOZ
• UDI-Device Identifier: 00801902099471
• UDI-Public: 00801902099471
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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
• Device Expiration Date: 09/21/2024
• Device Catalogue Number: CDA-45703-P1A
• Device Lot Number: 13F23A0221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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 REPORTED; NOT REPORTED
• Patient Age: 10 YR
• Patient Sex: Male