MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04018-UPM
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "catheter was crushed".A new kit was used to finish the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "catheter was crushed".A new kit was used to finsih the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, single-lumen arterial catheter and the product lidstock for analysis.Signs of use in the form of biological material were observed on and within the catheter.However, additional information from the customer suggests the damage to the catheter was observed prior to use.Visual analysis revealed the distal end of the catheter appeared crushed and bent.The damage on the catheter appears consistent with a pinching/crushing force on the catheter body.The damage on the catheter measured 25 mm - 64 mm from the distal tip.The catheter body length measured 5 31/32", which is within the specification limits of 5 13/16"-6 3/16" per catheter product drawing.The outer diameter of the catheter body measured 0.058", which is within the specification limits of 0.055"-0.059" per catheter extrusion product drawing.The catheter was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "thread tip of catheter over guidewire.Indwelling catheter should be routinely inspected for desired patency, security of dressing, and possible migration." a lab inventory 0.025" guide wire (measured 0.024") was advanced through the returned catheter.Resistance was met at the locations of damage; however, the guide wire was able to advance through the undamaged portions of the catheter with little to no resistance.A lab inventory syringe filled with water was used to flush the catheter.No signs of leakages or blockages were observed.Manufacturing was contacted as a part of this complaint investigation.They confirmed the packaging configuration of finished good ask-04018-upm includes cavities in the tray to hold each component and a seal that would hold all components in place.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user , "some disinfectants used at catheter insertion site contains solvents which can weaken the catheter material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials.Precaution: use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire." the customer report of a damaged catheter was confirmed through complaint investigation of the returned sample.The distal end of the catheter appeared crushed and bent.The damage on the catheter appears consistent with a pinching/crushing force on the catheter body.Despite this, the catheter met all relevant dimensional requirements.A device history record review was performed, and no relevant findings were identified.Due to the discrepancy between the customer report (damage observed prior to use) and the sample received (evidence of use), the probable cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM
• 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: 20459560
• Report Number: 9680794-2024-01026
• Device Sequence Number: 8855743
• Product Code: DQX
• UDI-Device Identifier: 50801902117644
• UDI-Public: (01)50801902117644(11)231029(17)260228(10)33F23K0747(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: ASK-04018-UPM
• Device Lot Number: 33F23K0747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown