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

Catalog Number ES-04706

Device Problem Unraveled Material (1664)

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

Event Date 03/26/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

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

Manufacturer Narrative

(b)(4).The customer returned one opened cvc set including: a guide wire in its advancer, a 1-l catheter, an arrow raulerson syringe (ars), and an 18ga introducer needle for analysis.No signs of use were observed.Visual inspection revealed that there were no kinks on the guide wire.Microscopic examination confirmed both welds were present and spherical.The guide wire total length measured 456mm, which is within the specification limits of 450-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.801mm, 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 arrow raulerson syringe (ars)/introducer needle assembly.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 the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The 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 swg kinked was not able to be confirmed through analysis of the returned sample.There were no kinks or other signs of damage observed on the guide wire.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, no root cause could be determined as there was no problem found on the sample.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported the spring wire guide unraveled during use on the patient.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: 16770815
• MDR Text Key: 313596902
• Report Number: 3006425876-2023-00385
• 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: 03/26/2023

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 Catalogue Number: ES-04706
• Device Lot Number: 71F19M1201
• 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: 03/26/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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