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 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the doctor found the swg kinked during used on the patient".No medical intervention needed.The patient's current condition is reported as "fine.

Manufacturer Narrative

Qn#(b)(4).The customer provided one photo for analysis.The complaint of a kinked wire could not be confirmed by the customer provided photo.The image shows the contents of a cvc set; however, the guide wire is not pictured.The customer also returned an opened cvc kit including one, 2-lumen catheter for evaluation.The guide wire assembly and 18ga introducer needle was not returned.No evidence of use was observed on the returned components.Visual analysis could not be performed on the guide wire as it was not returned.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit 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 not confirmed through examination of the returned sample.The guide wire was not within the returned kit.A device history record review did not identify any manufacturing related issues.Based on these circumstances, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the doctor found the swg kinked during used on the patient".No medical intervention needed.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: 18684348
• MDR Text Key: 335109937
• Report Number: 3006425876-2024-00090
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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 Operator: Health Professional
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F22H1984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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