MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CS-15802-E

Device Problems Difficult to Remove (1528); Material Separation (1562); Unraveled Material (1664)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, the swg removal was difficult during use on the patient.Visual examination of the returned device showed that the device was unravelled.There was no reported patient harm or consequence from the incident.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that"(b)(6) 2023, the swg removal was difficult during use on the patient.Visual examination of the returned device showed that the device was unravelled.There was no reported patient harm or consequence from the incident.

Manufacturer Narrative

(b)(4).The customer returned one unraveled guide wire for analysis.No definite signs of use were observed.Visual analysis revealed that the guide wire was separated and unraveled from the proximal end.The proximal end and weld of the guide wire was not returned for analysis.Multiple kinks were also observed along the guide wire body.Microscopic examination.Confirmed the damage.It was also noted that the distal weld was spherical and intact; however, the distal j-bend was observed to be misshapen.The major kinks in the guide wire measured 41mm, 470mm, and 561mm from the distal weld.The overall length of the guide wire core wire measured 575mm, which is not within the specification of 596mm-604mm per guide wire product drawing.This indicates that at least 21mm was not returned for analysis.The outer diameter of the guide wire measured 0.795mm which is within the od specification of 0.0788mm-0.826mm per guide wire product drawing.Functional testing could not be performed due to the damage to the guide wire.A manual tug test confirmed that the distal weld was 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 report of a separated guide wire was confirmed through examination of the returned sample.Visual analysis revealed that the core wire was broken and the proximal end and weld of the guide wire was not returned.The guide wire met all relevant 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.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 CVC SET: 2-LUMEN 8 FR X 20 CM
• 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: 17660000
• MDR Text Key: 322373349
• Report Number: 3006425876-2023-00909
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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 Catalogue Number: CS-15802-E
• Device Lot Number: 71F22H3871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED