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

Catalog Number CA-22703

Device Problem Material Separation (1562)

Patient Problems Cardiac Arrest (1762); Injury (2348); No Information (3190)

Event Date 02/21/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).Additional information regarding this event was requested.No additional information received at the time of this report.

Event Description

On (b)(6) 2020, during insertion of the arrow cl, the needle broke at the hub and the metal portion separated from the plastic.The metal caused a traumatic injury to the patient's heart.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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

On (b)(6) 2020, during insertion of the arrow cl, the needle broke at the hub and the metal portion separated from the plastic.The metal caused a traumatic injury to the patient's heart.

Manufacturer Narrative

Qn# (b)(4).Additional information was received from the user facility.It was reported that the "metal portion of the needle broke off plastic hub and embolized from the subclavian vessel to the superior vena cava causing a puncture of the right atrium, vena cava and pulmonary artery".It was also reported there was "immediate recognition of the problem with immediate cardiac arrest and subsequent exploration of the chest by thoracic surgery".The patient is deceased and the customer reports that the device has contributed to the patient's death.

Event Description

On (b)(6) 2020, during insertion of the arrow cl, the needle broke at the hub and the metal portion separated from the plastic.The metal caused a traumatic injury to the patient's heart.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9756503
• MDR Text Key: 185252484
• Report Number: 9680794-2020-00127
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

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: No Information
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: CA-22703
• Device Lot Number: 13F19K0517
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 04/08/2020; 04/08/2020
• Supplement Dates FDA Received: 04/08/2020; 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.; UNKNOWN.
• Patient Outcome(s): Death; Life Threatening; Other; Required Intervention