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

Catalog Number CS-27702-E

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: on (b)(6) 2023, the doctor found the swg can't pull out of the catheter.The swg kinked during used on the patient.

Event Description

It was reported that: (b)(6) 2023, the doctor found the swg can't pull out of the catheter.The swg kinked during used on the patient.

Manufacturer Narrative

Qn# (b)(4).The customer returned one guide wire inserted through a 2-lumen cvc for analysis.The kit lidstock was also returned.Signs of use in the form of biological material were observed.Visual analysis revealed that the guide wire was kinked in sections from within and outside the catheter body.The guide wire was removed, and five major kinks were noted.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kinks on the guide wire measured 15mm, 358mm, 429mm, 470mm, and 578mm from the proximal weld.The guide wire total length measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.790mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The catheter body length measured 215mm, which is within the specification limits of 207mm-227mm per the catheter body product drawing.The catheter body outer diameter measured 2.46mm, which is within the specification limits of 2.36mm-2.46mm per the catheter extrusion product drawing.The guide wire was removed from the catheter body.Congealed biological material was observed exiting the catheter body, which created slight resistance when removing the guide wire.The biological material was removed, and the guide wire was reinserted.Slight resistance was encountered at the kinks; however, all functional sections of the guide wire passed with little to no issue.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".A manual tug test confirmed that the distal and proximal welds were 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 obta ined and further consultation requested".The report of a kinked guide wire due to catheter resistance was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked in five locations across the body.The kinks in combination with congealed biological material from inside the catheter created resistance was advancing the guide wire.Despite the damage, the catheter and guide wire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely 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 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 18631994
• MDR Text Key: 334499631
• Report Number: 3006425876-2024-00130
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: 00801902102362
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

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: CS-27702-E
• Device Lot Number: 71F23B0233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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.