MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN030108

Device Problems Material Separation (1562); Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during catheter insertion, it was difficult to advance the catheter through the wire.There was no kink in the wire visible.When attempting to rethread the catheter, the wire could no longer be moved.After some increased tension on the wire, the wire broke.The catheter and wire were removed from the patient and a new set was used.No patient harm reported.The patient's condition was reported as critical unrelated to the device.

Manufacturer Narrative

Qn#(b)(4).The customer provided one photo of the catheter and guide wire, with a circle drawn around the rotating hub.The customer returned a single guide wire and 2-lumen cvc catheter for evaluation.The components showed evidence of use in the form of dried blood.Visual examination revealed the guide wire is unraveled from the distal weld and contains one kink along the body.The guide wire distal j-bend is intact.The returned catheter shows evidence of use but no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire is broken adjacent to the distal weld.Both welds are present and appeared full and spherical.Microscopic examination of the catheter and insertion components did not reveal any defects or anomalies.The kink in the guide wire body was measured at 519mm from the proximal tip.The broken core wire measured 599 mm in length which is within the specification of 596-604 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 0.850 mm which is within the outer diameter specification of 0.838-0.877 mm per guide wire product drawing.The "catheter" body length measured 167 mm which is within the specification of 157-177 mm per catheter product drawing.A lab inventory guide wire with the same diameter as the guide wire involved with this complaint (.877mm) was inserted through the catheter.When first "inserting" the guide wire, major resistance was experienced.Minor force was then applied when threading the guide wire, which resulted in dried blood within the catheter to be loosened and expelled.Once the blood was removed, little to no resistance was observed as the guide wire passed completely through the catheter body.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guide wire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire.Grasping near skin, advance catheter into vein with slight twisting motion".A manual tug test confirmed that the proximal weld was intact.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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 distal weld.The guide wire and catheter met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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 these circumstances, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported during catheter insertion, it was difficult to advance the catheter through the wire.There was no kink in the wire visible.When attempting to rethread the catheter, the wire could no longer be moved.After some increased tension on the wire, the wire broke.The catheter and wire were removed from the patient and a new set was used.No patient harm reported.The patient's condition was reported as critical unrelated to the device.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Type of Device: 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: 14249954
• MDR Text Key: 290381497
• Report Number: 3006425876-2022-00383
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: 00801902102188
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN030108
• Device Catalogue Number: CS-22123-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1