MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 4FR X 8CM; CATHETER, PERCUTANEOUS

Model Number IPN917451

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

Patient Problems Cardiac Arrest (1762); Foreign Body In Patient (2687)

Event Date 12/15/2023

Event Type  Death  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "urgent insertion of a cvc on the right side following a cardiac arrest of a female 13 and half month.The insertion was done with no problem.Blood flow and vein access was confirmed on all 3 lumens.Impossible to remove the swg, it seems that it is stuck in the deep subcutaneous area, despite having removed the catheter to help with the swg removal.The swg unravels due to traction and broke off leaving 2.5cm in intravascular.An x-ray was performed after the incident showed that the swg's tip knotted.This incident delayed the treatment.Despite the insertion with no issues of a second cvc on the left side, the patient dies of another cardiac arrest.The medical staff confirmed that the device is not contributory of the death, but it complicated the reanimation.The swg has been retained.The knotted part hasn't been removed.".

Manufacturer Narrative

(b)(4).The customer provided two photos for analysis.The first photo showed the removed portion of the guidewire.The second photo showed a patient x-ray which appeared to reveal evidence of a separated and knotted portion of the guidewire retained within the patient.Feedback from clinical and medical affairs (cma) aligned with this visual analysis.Therefore, the complaint of guidewire knotted in patient was able to be confirmed based on the provided photos.The customer also returned one portion of a guidewire for investigation.As reported, the separated, distal portion that was shown in the patient x-ray was not returned.Visual inspection revealed that the guidewire was separated at its distal end.Multiple offset coils were identified near the point of separation which indicate that resistance was encountered during use.Microscopic imaging confirmed the damage.The guidewire length measured at 410mm, which is not within specification of 444mm-456mm per product drawing.This indicates that approximately 40mm of the distal portion of the guide was separated and retained in the patient, as reported.The outer diameter of the guidewire measured at 0.443mm which is within specification of 0.43-0.46mm per product drawing.Functional inspection could not be performed due to the condition of the returned wire.A manual tug test confirmed that the proximal weld was fully intact.Clinical and medical affairs was previously contacted regarding this complaint.It was determined that the guide wire can become looped around the catheter as part of the insertion process.This is likely due to the catheter advancing and retracting multiple times which can cause looping and knotting of the wire.Per cma, although no resistance was reported when introducing the guidewire, it is possible that the subtle signs of resistance may have been missed during the insertion of the wire or catheter due to the emergent nature of the case as described in the report.Additionally, the guidewire would be unable to be threaded through the insertion needle and/or catheter while containing a knot, which indicates that the guidewire became knotted in use, after a successful insertion.However, since the separated, distal portion of the guidewire was not returned for investigation, a complete analysis could not be performed and the root cause of this event cannot be determined.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.Precaution: if resistance is encountered when attempting to remove guidewire after catheter placement, guidewire may be kinked around tip of catheter within vessel.In this circumstance, pulling back on guidewire may result in undue force being applied resulting in guidewire breakage.If resistance is encountered, withdraw catheter relative to guidewire about 2-3 cm and attempt to remove guidewire.If resistance is again encountered, remove guidewire and catheter simultaneously." the complaint of guidewire knotted in patient was confirmed based on the customer photos supplied, sample received, and clinical review.The first photo showed the removed portion of the guidewire.The second photo showed a patient x-ray which appeared to reveal evidence of a separated and knotted portion of the guidewire retained within the patient.Feedback from clinical and medical affairs (cma) aligned with this visual analysis.Visual inspection of the returned guidewire revealed that the guidewire was separated at its distal end.Multiple offset coils were identified near the point of separation which indicate that resistance was encountered during use.Dimensional analysis did not reveal any manufacturing related issues.Clinical and medical affairs determined that the guidewire can become looped around the catheter as part of the insertion process.This is likely due to the catheter advancing and retracting multiple times which can cause looping and knotting of the wire.Per cma, although no resistance was reported when introducing the guidewire, it is possible that the subtle signs of resistance may have been missed during the insertion of the guidewire or catheter due to the emergent nature of the case described in the report.Additionally, the guidewire would be unable to be threaded through the insertion needle and/or catheter while containing a knot, which indicates that the guidewire became knotted in use, after a successful insertion.A device history record review was performed with no findings identified.However, since the separated, distal portion of the guidewire was not returned for investigation, a complete analysis could not be performed and the root cause of this event cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "urgent insertion of a cvc on the right side following a cardiac arrest of a female 13 and half month.The insertion was done with no problem.Blood flow and vein access was confirmed on all 3 lumens.Impossible to remove the swg, it seems that it is stuck in the deep subcutaneous area, despite having removed the catheter to help with the swg removal.The swg unravels due to traction and broke off leaving 2.5cm in intravascular.An x-ray was performed after the incident showed that the swg's tip knotted.This incident delayed the treatment.Despite the insertion with no issues of a second cvc on the left side, the patient dies of another cardiac arrest.The medical staff confirmed that the device is not contributory of the death, but it complicated the reanimation.The swg has been retained.The knotted part hasn't been removed.".

• Brand Name: CVC SET: 3-LUMEN 4FR X 8CM
• 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: 18473871
• MDR Text Key: 332378967
• Report Number: 3006425876-2024-00052
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/15/2023

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: IPN917451
• Device Catalogue Number: EU-15403-N
• Device Lot Number: 71F23D1555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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.
• Patient Outcome(s): Death
• Patient Age: 13 MO
• Patient Sex: Female