MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS

Catalog Number ES-04706

Device Problems Unraveled Material (1664); Deformation Due to Compressive Stress (2889)

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

Event Date 03/25/2023

Event Type  malfunction  

Event Description

It was reported the nurse found the the spring wire guide unraveled during patient use.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned an opened cvc kit including: one spring wire guide (swg) in its advancer, a 1-lumen catheter, and an arrow raulerson syringe (ars) for evaluation.The guide wire had one kink at the distal end of the guide wire.Signs of use were observed on the swg assembly.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kink on the guide wire measured 25mm from the distal tip of the guide wire.The guide wire length measured 457mm, which is within the specification limits of 450mm-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.805mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The guide wire was inserted through the returned ars and a laboratory 18ga introducer needle assembly.Resistance was met when the guide wire was advanced through the ars due to a blockage which was observed to be biomaterial.The biomaterial in the ars was removed, and the guide wire was able to pass with little to no difficulty.Performed per ifu statement, "raise your thumb and pull the arrow advancer approximately 4 cm to 8 cm away from the syringe.Lower thumb onto the arrow advancer and while maintaining a firm grip on the spring-wire guide, push the assembly into the syringe barrel to further advance the spring-wire guide.Continue until spring-wire guide reaches desired depth".A manual tug test confirmed that the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user , "warning: do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested.The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed one bend at the distal end of the guide wire body.The guide wire met all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on the customer report that the damage was observed during use 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.

Event Description

It was reported the nurse found the spring wire guide unraveled during patient use.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 14 GA X 6" (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: 16771210
• MDR Text Key: 313751372
• Report Number: 3006425876-2023-00399
• 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: 03/27/2023

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 Catalogue Number: ES-04706
• Device Lot Number: 71F20K0733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• 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