MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CA-22703

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

The complaint is reported as: physician inserting three lumen cvc.Had no issue inserting the cvc and flushing medial and proximal ports.When trying to flush the distal port had issues removing the spring wire guide, kept catching.During removal, the guidewire "broke" and had to be clamped.The entire cvc was removed.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The photos revealed a swg fully inserted into a 3-l catheter that contained a major kink at its distal end.Unraveling was evident at the proximal end of the guide wire; however, it could not be confirmed if the guidewire was separated from the photos.The damage to the guide wire was confirmed by the customer provided photo; however, a complete visual inspection could not be performed as no sample was returned for analysis.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, "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." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: physician inserting three lumen cvc.Had no issue inserting the cvc and flushing medial and proximal ports.When trying to flush the distal port had issues removing the spring wire guide, kept catching.During removal, the guidewire "broke" and had to be clamped.The entire cvc was removed.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16386354
• MDR Text Key: 309662158
• Report Number: 9680794-2023-00073
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2024
• Device Catalogue Number: CA-22703
• Device Lot Number: 13F22F0405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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