MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14502

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the incident occurred when removing the catheter guide, the patient had a part of the catheter left in the artery.Guide frayed during use".It was reported the part that remained was "anchored" in the patient and was not removed.The patient was reported to be "fine" and was discharged from the hospital.

Manufacturer Narrative

Qn# (b)(4).The customer provided three images for analysis.The first image showed an x-ray of the separated portion of the guide wire inside the patient.The other two photos showed two severely unraveled/separated guide wires coiled together.The customer also returned one, opened cvc kit for analysis.It was noted that the customer returned two unra veled/separated guide wires for analysis.One that was separated from proximal end and one that was separated from the distal end.The customer was contacted as part of this discrepancy, and they indicated that only one guide wire was defective.From this and the original report that the separated portion was left in the patient and was not removed, the defective guide wire with the separated distal end is likely the guide wire involved with this complaint.After the defective guide wires were uncoiled from each other, visual analysis of the guide wire involved with this complaint confirmed that it was severely unraveled and separated from the distal end.The separated portion was not returned for analysis.One major kink was also observed towards the proximal end.Microscopic examination confirmed the separation and revealed that the proximal weld was secure and spherical.Visual analysis could not be performed on the separated portion of the guide wire as it was not returned for analysis.The kink measured 29mm from the proximal weld.The guide wire length from the proximal weld to the point of separation on the core wire measured 16 7/16", which indicates that 1 1/4"-1 5/8" of the guide wire had separated and was not returned (per the guide wire product drawing).The guide wire outer diameter measured.511mm, which is within the specification limits of.508mm-.533mm per the guide wire product drawing.The guide wire length could not be accurately verified as the separated portion was not returned with the rest of the sample.Functional analysis could not be performed due to the severity of the damage on the guide wire involved with this complaint.A manual tug test confirmed that the proximal weld was secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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".The ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report of a separated guide wire was confirmed through complaint investigation of the returned sample and customer supplied photos.Visual analysis revealed that the guide wire was severely unraveled/separated from the distal end; however, a full visual analysis could not be performed on the separated portion as it was not returned for analysis.Likewise, a full dimensional analysis could not be performed to confirm the guide wire length.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 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 the returned sample and the report from the customer, the root cause for this issue appears consistent with damage due to undue force applied during insertion/removal; however, this cannot be confirmed without the separated portion also returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "the incident occurred when removing the catheter guide, the patient had a part of the catheter left in the artery.Guide frayed during use." it was reported the part that remained was "anchored" in the patient and was not removed.The patient was reported to be "fine" and was discharged from the hospital.

• Brand Name: ARROW CVC SET: 2-LUMEN 5 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: 16101610
• MDR Text Key: 306686512
• Report Number: 9680794-2023-00007
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K862056
• 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: 12/09/2022

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 Expiration Date: 03/31/2024
• Device Catalogue Number: CS-14502
• Device Lot Number: 14F19D0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2019
• 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): Other