MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number IPN918748

Device Problem Unraveled Material (1664)

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

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "during insertion of a portacath, the guide deteriorated.The guide unravelled over 5 millimeters.The anaesthetist realized this when he had difficulty removing the guide." no patient injury or consequence reported.Patient condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer provided two images for analysis.The images show the unraveling of the coil wire on a portion of the guide wire body.The customer also returned one guide wire and catheter for evaluation.The guide wire was noted to be partially unraveled, and signs of use were observed.It was noted that the catheter returned is not the catheter provided in the reported finished kit (2-lumen catheter).Visual inspection of the guide wire revealed that a portion of the coil wire unraveled from the middle of the guide wire body.The unraveled portion contained a loop which is consistent with the appearance of a single coil of the coil wire.The nature of the separation point of the coil wire is consistent with damage resulting from contact with a sharp instrument (i.E.The needle bevel).Microscopic examination confirmed the damage.No damage was observed to the core wire.Both welds were present and were observed to be spherical.The overall length of the guide wire measured 455mm which is within the specifications of 450-458mm per product drawing.This indicates that no pieces of the core wire appear to be missing.The guide wire outer diameter measured 0.801mm which is within the specifications of 0.788-0.826mm per product drawing.Per the instructions for use (ifu) provided with this kit, the user is instructed to "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." with the observed damage, the guide wire would not successfully advance through the introducer needle.Based on the customer report that the damage was identified upon removal of the guide wire, the damage likely occurred after insertion of the guidewire through the syringe and needle.The guide wire was functionally tested per the ifu which states "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire.".The guide wire was threaded through the returned catheter and the undamaged portions of the guide wire passed with little to no resistance.Resistance was experienced at the unraveled portion of the guide wire.R & d was consulted as part of this complaint investigation.They stated that the appearance of the guide wire damage is consistent with it getting cut through force or interaction with a sharp instrument.The customer additionally stated that the damage was observed when they "had difficulty removing the guide", which supports that the damage was likely observed after insertion of the guide wire.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the ifu also states, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guide wire was unraveled was confirmed through examination of the returned sample.Visual inspection revealed that the coil wire was unraveled from the middle of the body (the core wire was undamaged) and the appearance of the separation points of the coil wire are consistent with contact with a sharp instrument (i.E.Needle bevel).The customer additionally stated that the damage was observed when they "had difficulty removing the guide", which supports that the damage was likely observed after insertion of the guide wire.Dimensional and functional inspections as well as a device history record review did not reveal any evidence of a manufacturing related issue.Based on the customer report, sample received unintentional use error due to contact with a sharp instrument (needle bevel), likely contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported "during insertion of a portacath, the guide deteriorated.The guide unravelled over 5 millimeters.The anaesthetist realized this when he had difficulty removing the guide." no patient injurty or consequence reported.Patient condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 16 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: 18518753
• MDR Text Key: 333087148
• Report Number: 3006425876-2024-00043
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902104738
• UDI-Public: 10801902104738
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

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 Operator: Health Professional
• Device Model Number: IPN918748
• Device Catalogue Number: CS-12802
• Device Lot Number: 71F23B1936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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: NONE REPORTED.; NONE REPORTED.