MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-42802

Device Problems Entrapment of Device (1212); Deformation Due to Compressive Stress (2889)

Patient Problems Cardiac Arrest (1762); Hemothorax (1896)

Event Date 11/26/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "the incident involved a 13-year-old child.Incident occurred on (b)(6) 2022.There was a difficulty during the insertion of the cvc via ultrasound-guided in left supraclavicular.After a single puncture, the guidewire advanced easily but an abnormal bleeding was observed, around the "j" guidewire before any dilation.A thoracic x-ray was performed, it showed a wrong path course of the guide with a winding of the guide at the level of the superior mediastinum.Guide was removed and got blocked because it kinked.Follow-up x-ray was performed, no anomaly was identified.The x-ray confirmed the correct positioning of the central venous catheter, no abnormality.1h30 after the first attempt of catheterization, the etc02 dropped with impossible ventilation followed by a first cardiac arrest.Identification of a massive right hemothorax.Second cardiac arrest occurred, resulting in patient death despite resuscitation attempts." additional information was received that the patient was in the operating room in preparation for a liver transplant when the event occurred.It was a "unique (and easy) ultrasound-guided puncture, the guide advanced without any problem but observation of unusual bleeding after insertion of the guide, and before any dilation".An x-ray was performed and showed "a wrong path course" of the guidewire and "then during the difficult removal of the guide" a kink in the guidewire.A small incision was made at the base of the puncture site and after complete removal of the guidewire, x-ray showed no complication at that time.The user "attempted insertion in the left internal jugular with no success to advance guide further than the needle, then cvc inserted in the right internal jugular vein without difficulty".Ventilatory levels were normal before sudden deterioration and there was no hemodynamic abnormality in the context of anesthetic induction.It was reported "there was a sudden deterioration.A pnemo-pulmonary ultrasound and x-ray were performed which showed a hemothorax, confirmed by a thoracic drainage followed by a thoracotomy which identified a bleeding of mediastinal origin." the hemothorax occurred on the right side due to "diffusion of hemomediastinum in the right hemithorax".The patient died on (b)(6) 2022 due to "hemorrhagic complication with cardiac arrest following a probable vascular rupture".An autopsy was not performed.

Event Description

It was reported that: "the incident involved a 13-year-old child.Incident occurred on (b)(6) 2022.There was a difficulty during the insertion of the cvc via ultrasound-guided in left supraclavicular.After a single puncture, the guidewire advanced easily but an abnormal bleeding was observed, around the "j" guidewire before any dilation.A thoracic x-ray was performed, it showed a wrong path course of the guide with a winding of the guide at the level of the superior mediastinum.Guide was removed and got blocked because it kinked.Follow-up x-ray was performed, no anomaly was identified.The x-ray confirmed the correct positioning of the central venous catheter, no abnormality.1h30 after the first attempt of catheterization, the etc02 dropped with impossible ventilation followed by a first cardiac arrest.Identification of a massive right hemothorax.Second cardiac arrest occurred, resulting in patient death despite resuscitation attempts." additional information was received that the patient was in the operating room in preparation for a liver transplant when the event occurred.It was a "unique (and easy) ultrasound-guided puncture, the guide advanced without any problem but observation of unusual bleeding after insertion of the guide, and before any dilation".An x-ray was performed and showed "a wrong path course" of the guidewire and "then during the difficult removal of the guide" a kink in the guidewire.A small incision was made at the base of the puncture site and after complete removal of the guidewire, x-ray showed no complication at that time.The user "attempted insertion in the left internal jugular with no success to advance guide further than the needle, then cvc inserted in the right internal jugular vein without difficulty".Ventilatory levels were normal before sudden deterioration and there was no hemodynamic abnormality in the context of anesthetic induction.It was reported "there was a sudden deterioration.A pnemo-pulmonary ultrasound and x-ray were performed which showed a hemothorax, confirmed by a thoracic drainage followed by a thoracotomy which identified a bleeding of mediastinal origin." the hemothorax occurred on the right side due to "diffusion of hemomediastinum in the right hemithorax".The patient died on (b)(6) 2022 due to "hemorrhagic complication with cardiac arrest following a probable vascular rupture".An autopsy was not performed.

Manufacturer Narrative

(b)(4), the customer did not return a complaint sample; however, six x-ray images were provided for analysis.Clinical and medical affairs was consulted, and they indicated that there were no definitive conclusions about the event that occurred or performance of the guide wire that can be determined from the photos without the x-ray images in their original quality.Therefore, the complaint of a guide wire stuck inside a patient was not able to be confirmed by the photos.Additionally, a complete visual inspection could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, two potential lot numbers were obtained from the sales history of the customer.A device history record was performed on the two potential lot numbers and no relevant findings were identified.The ifu provided with the kit informs the user, "clinicians must be aware of potential entrapment of the guidewire by any implanted device in circulatory system.It is recommended that if patient has a circulatory system implant, catheter procedure be done under direct visualization to reduce risk of guidewire entrapment".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 customer report of a guide wire stuck inside a patient was not able to be confirmed.No definitive conclusions could be determined from the x-ray photos provided by the customer.In addition, full complaint verification testing could not be performed as no sample was returned for analysis.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.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 16 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: 16147283
• MDR Text Key: 307185306
• Report Number: 3006425876-2023-00065
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

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 Operator: Health Professional
• Device Catalogue Number: CS-42802
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 39 KG