MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER PERCUTANEOUS

Catalog Number CS-15402-E

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2023

Event Type  Injury  

Event Description

It was reported during insertion, the guidewire "is stretched and it is impossible to insert the catheter".Additional information received reported "the overall guidewire was stretched, but the tip was stretched and in addition, split, becoming lodged in the left subclavian vein pathway." and that "control chest x-ray showed that the foreign body was in the left subclavian vein, in the initial location where it had been lodged, the patient was referred and accepted to another institution for pediatric hemodynamics for foreign body removal".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.Warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." 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.

Event Description

It was reported during insertion, the guidewire "is stretched and it is impossible to insert the catheter".Additional information received reported "the overall guidewire was stretched, but the tip was stretched and in addition, split, becoming lodged in the left subclavian vein pathway." and that "control chest x-ray showed that the foreign body was in the left subclavian vein, in the initial location where it had been lodged, the patient was referred and accepted to another institution for pediatric hemodynamics for foreign body removal".

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 8 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17769195
• MDR Text Key: 323658766
• Report Number: 9680794-2023-00674
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902099645
• UDI-Public: 10801902099645
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K862056
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-15402-E
• Device Lot Number: 14F22G0324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization