MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 01/20/2023

Event Type  malfunction  

Event Description

It was reported during the procedure, the physician found the guidewire kinking and bent.An new kit was opened to finish the procedure.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported during the procedure, the physician found the guidewire kinking and bent.An new kit was opened to finish the procedure.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned an opened three-lumen cvc kit including: the lidstock, one guide wire in its advancer , an arrow raulerson syringe, a three-lumen catheter, a dilator, an introducer needle, and transduction probe for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the guide wire contained one kink near the distal end.Offset coils and small kinking was observed on the j-bend.Microscopic examination confirmed the damage and revealed that the distal and proximal welds are full and spherical.The kink near the j-bend measured 81mm from the distal weld.The guide wire length measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.800 mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The guide wire was inserted through the provided arrow raulerson syringe (ars)/introducer needle assembly.The guide wire was able to pass with little difficulty due to the kink and biomaterial.Performed per ifu statement, "raise thumb and pull arrow advancer approximately 4 - 8 cm away from arrow raulerson syringe or introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into syringe barrel to further advance guidewire.Continue until guidewire reaches desired depth." 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 use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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 of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed one kink on the guide wire near the distal end.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.

• Brand Name: ARROW CVC SET: 3-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: 16432518
• MDR Text Key: 310153260
• Report Number: 3006425876-2023-00158
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F22E1073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• 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: NOT REPORTED; NOT REPORTED