MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CV-17702-E

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported "the swg was found kinked during used on the patient".The user changed to a new set.No medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The customer returned one, opened cvc kit including one guide wire within its advancer, a 2-lumen catheter , and an arrow raulerson syringe (ars) for analysis.Signs of use were observed on the guide wire.The guide wire was observed to have two kinks towards the distal end of the body.The distal j-bend was slightly misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The kinks in the guide wire were located 470 mm and 530 mm from the proximal tip.The overall length of the guide wire measured 601 mm which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.796 mm which is within the specification limits of 0.788-0.826 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The undamaged portions of the guide wire passed through both components with little to no resistance.The ifu also 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 were able to advance through with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "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 that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire had two kinks towards the distal tip.The returned guide wire met all relevant dimensional/ functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use , unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the swg was found kinked during used on the patient".The user changed to a new set.No medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 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: 19014048
• MDR Text Key: 339128417
• Report Number: 3006425876-2024-00323
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902105455
• UDI-Public: 00801902105455
• 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,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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: CV-17702-E
• Device Lot Number: 71F22E0494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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: NONE REPORTED.; NONE REPORTED.