MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18GA X 23CM; CATHETER PERCUTANEOUS

Model Number IPN920507

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

Patient Problem Hematoma (1884)

Event Date 07/11/2023

Event Type  Injury  

Event Description

It was reported that: "during the insertion of the arterial catheter, the doctor punctured to introduce the guide, there was no problem.The doctor removed the needle to insert the catheter, there was no problem.He inserted the catheter and tried to remove the guide and this was impossible.The doctor felt a resistance.He felt something was blocking.He pulled a little harder and there the guide felt apart, the iron wire unravelled." there was a delay in treatment and the patient had a "significant hematoma at the puncture site".Additional information was requested but was not available at the time of this report.

Manufacturer Narrative

Qn#: (b)(4).

Manufacturer Narrative

(b)(4).Additional information received from the customer 11-aug-2023 indicates the entire guide wire was removed and a second kit was used successfully.It was also reported that a femostop device was required.The customer returned one guide wire and one arterial catheter for analysis.Definite signs of use were observed in the form of dried biomaterial within the catheter tip and on the catheter body.The guide wire was returned unraveled and advanced through the catheter.The guide wire was removed from the catheter to further analyze the components.Visual analysis of the guide wire revealed that the core wire was broken adjacent to the proximal weld and the weld was present at the end of the coil wire.The catheter had severe kinking at the proximal end of the body near the juncture hub.Widening of the catheter tip was noted which is indicative of excessive force during the removal of the guidewire.Microscopic examination confirmed the damage to both components, and revealed that both welds were present and appeared full and spherical.The core wire point of separation was adjacent to the weld.The guide wire core wire length measured 601mm, which is within the specification limits of 596mm-604mm per the product drawing; therefore no pieces of the core wire appear to be missing.The outer diameter of the undamaged portion of the guide wire measured 0.610mm, which is within the specification limits of 0.610mm-0.635mm per the product drawing.The catheter body length measured 230mm, which is outside of the specification limits of 242mm-244mm per the catheter product drawing.This was likely due to the severe kinking at the proximal end of the catheter which shortened the catheter extrusion.The components were functionally tested per the instructions for use (ifu) provided with this kit, which states "thread tip of catheter over guidewire." the undamaged portion of the guide wire was advanced through the returned catheter, and was unable to pass through the catheter.Major resistance was experienced at the location of the catheter kinks at the proximal end.Biological material was also observed within the distal end of the catheter extrusion.This in addition to the catheter kinking and widened catheter tip that were observed indicate that unintentional use error likely caused or contributed to the resistance experienced during use.A manual tug test confirmed that the distal weld was fully secured onto the guide wire.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 complaint of the guidewire unraveling was confirmed based on the investigation of the returned sample.Visual analysis of the guide wire revealed that the core wire was broken adjacent to the proximal weld.The returned catheter had severe kinking at the proximal end of the body and widening of the catheter tip.Dimensional evaluation of the returned components did not reveal any evidence of a manufacturing dimensional issue.A device history record review was peformed with no relevant findings.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 likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section h.1.-type of reportable event corrected to 'serious injury' based on additional information received.

Event Description

It was reported that: "during the insertion of the arterial catheter, the doctor punctured to introduce the guide, there was no problem.The doctor removed the needle to insert the catheter, there was no problem.He inserted the catheter and tried to remove the guide and this was impossible.The doctor felt a resistance.He felt something was blocking.He pulled a little harder and there the guide felt apart, the iron wire unravelled." there was a delay in treatment and the patient had a "significant hematoma at the puncture site".

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 23CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: 17504612
• MDR Text Key: 321059111
• Report Number: 3006425876-2023-00735
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171146
• 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: 07/18/2023

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 Operator: Health Professional
• Device Model Number: IPN920507
• Device Catalogue Number: SAC-02318-PBX
• Device Lot Number: 71F22H1487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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
• Treatment: NOT REPORTED; NOT REPORTED