MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETERIZATION KIT: 18 GA X 6"; WIRE, GUIDE, CATHETER

Model Number	IPN036984
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the product was being removed as therapy was done.The nurse pulled the hub from catheter body and the body "lodged in the vein".The patient was sent to interventional radiology and the catheter was successfully removed.The patient's condition is reported to be fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one arterial catheter for analysis.Signs of use in the form of biological material was observed inside the catheter body.Visual analysis revealed that the catheter body became separated directly adjacent to the hub.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform.The appearance of the damage is consistent with damage resulting from contact with a sharp instrument (i.E.Scissors, scalpe, etc.).It was also observed that the catheter was separated directly adjacent to the distal tip.This separated tip was not returned for analysis.The catheter was separated approximately 1mm from the hub.The separation towards the tip measured approximately 163mm from the separation adjacent to the hub.Despite that a portion of the catheter tip not returned by the customer, the catheter body total length measured 6 1/16" which is within the specification limits of 5 13/16"-6 3/16" per the catheter product drawing.The catheter body outer diameter measured.057" which is within the specification limits of.055"-.059" per the catheter extrusion product drawing.The catheter body inner diameter at the proximal end measured.037" which is within the specification limits of.037"-.039" per the catheter extrusion product drawing.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "once the catheter is partially threaded off the needle, do not attempt to advance needle into catheter again - this may cause catheter damage." the report of a separated arterial catheter was confirmed through complaint investigation.Visual and microscopic analysis revealed that the catheter body was separated adjacent to the catheter hub.The appearance of the separation appears smooth and uniform and is consistent with damage resulting from contact with a sharp instrument (i.E.Scissors, scalpel, etc.).The catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the defect was observed during use and the appearance of the damage, unintentional use error likely 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 the product was being removed as therapy was done.The nurse pulled the hub from catheter body and the body "lodged in the vein".The patient was sent to interventional radiology and the catheter was successfully removed.The patient's condition is reported to be fine.

• Brand Name: ARROW ARTERIAL CATHETERIZATION KIT: 18 GA X 6"
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 14272942
• Report Number: 9680794-2022-00276
• Device Sequence Number: 4438909
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: 50801902117644
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: IPN036984
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 13F22A0877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown