MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB+; CATHETER INTRAVASCULAR THERAP

Catalog Number	AK-42703-P1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Cough (4457)
Date of Event	12/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "upon removal of the catheter, it was noted that the tip was missing.Imaging confirmed that the tip was still in the patient.Attempts to remove the catheter tip/fragment were unsuccessful.There were no complications during line placement.Removal of the line went well and was without difficulty".Additional information: patient was brought to the cath lab to attempt to remove the tip but they were unsuccessful.The patient was discharged home with the tip still in the vessel.The patient informed the md about a persistent cough sometime later.They are due to see a respiratory specialist to determine whether the fragment needs to be removed.Awaiting additional information.
Additional Manufacturer Narrative
(b)(4).The customer returned one three-lumen cvc catheter for investigation.Visual examination of the catheter body confirmed that the distal catheter tip was missing from the device.Microscopic examination of the distal catheter confirmed the damage and revealed a deformed and pinched catheter extrusion that is partially sealed together.This damage is indicative of thermal deformation to the plastic catheter extrusion.Additional information was received from the customer that confirmed that a thermal application was used during the procedure with this catheter.This statement aligns with the damage observed as the point of separation on the catheter extrusion revealed clear signs of thermal deformation.The returned catheter body measured 5 3/4" which is not within the specification of 7 13/32" - 7 15/32" per product drawing.This confirms that the catheter tip was separated from the body and not returned.Functional testing could not be performed based on the condition of the returned sample.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not alter the catheter , guidewire or any other kit/set component during insertion, use or removal.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of a catheter tip separation was confirmed through complaint investigation of the returned sample.Visual examination of the catheter body confirmed that the distal catheter tip was missing from the device.Microscopic examination of the distal catheter confirmed the damage and revealed a deformed and pinched catheter extrusion that is partially sealed together.This damage is indicative of thermal deformation to the plastic catheter extrusion.Additional information was received from the customer that confirmed that a thermal application was used during the procedure with this catheter.This statement aligns with the damage observed as the point of separation on the catheter extrusion revealed clear signs of thermal deformation.A device history record review was performed based on a potential lot from sales history and did not reveal any relevant findings to suggest a manufacturing issue.Based on the customer report, additional information provided, and the returned sample, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "upon removal of the catheter, it was noted that the tip was missing.Imaging confirmed that the tip was still in the patient.Attempts to remove the catheter tip/fragment were unsuccessful.There were no complications during line placement.Removal of the line went well and was without difficulty".Additional information: patient was brought to the cath lab to attempt to remove the tip but they were unsuccessful.The patient was discharged home with the tip still in the vessel.The patient informed the md about a persistent cough sometime later.They are due to see a respiratory specialist to determine whether the fragment needs to be removed.*additional information was requested but not received at the time of this report.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB+
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18526588
• Report Number: 9680794-2024-00027
• Device Sequence Number: 17759527
• Product Code: FOZ
• UDI-Device Identifier: 60801902124342
• UDI-Public: 60801902124342
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

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: AK-42703-P1A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown