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

Catalog Number CV-15703-E

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "cvc placement in the subclavian region, that at the time of attempting to remove the guidewire, it stays inside the subclavian tissue.Another catheter is used for a second attempt of central access and to remove the first guidewire, but this failed after venous return.The guidewire was frayed." it was reported the first attempt was in the subclavian region and the guidewire got stuck.Surgery was required to remove the guidewire.A second attempt was made in the femoral region (captured in mdr # 3006425876-2022-00763).A peripheral venous access was placed.

Manufacturer Narrative

(b)(4).Additional information received indicates the spring wire guide (swg)separated and "only part of the swg stuck in the patient".Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section h.6.-medical device problem code corrected to 1562 based on additional information received.

Event Description

The complaint is reported as: "cvc placement in the subclavian region, that at the time of attempting to remove the guidewire, it stays inside the subclavian tissue.Another catheter is used for a second attempt of central access and to remove the first guidewire, but this failed after venous return.The guidewire was frayed." it was reported the first attempt was in the subclavian region and the guidewire got stuck.Surgery was required to remove the guidewire.A second attempt was made in the femoral region (captured in mdr # 3006425876-2022-00763).A peripheral venous access was placed.

• Brand Name: ARROW CVC SET: 3-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: 15332444
• MDR Text Key: 299036094
• Report Number: 3006425876-2022-00764
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV-15703-E
• Device Lot Number: 71F20K0907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 102 KG