MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-26702-E

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "patient in whom an ultrasound-guided central catheter is placed, left subclavian jugular via without complications, at the moment of removing the guide cannot be removed, it remains trapped, insists on its removal evidence that it's lost his memory at the end proximal, and it's unrolled, at the risk of staying inside the patient. It's tracked, presenting at the same time withdrawal of the guide and withdrawal of the vascular device (the guide is strongly adhered to the catheter). " no medical intervention was required. The device was removed and replaced. It was reported there was a delay in therapy without harm to the patient.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: 14189430
• MDR Text Key: 289961552
• Report Number: 3006425876-2022-00341
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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

• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F21F0388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial