MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-42703-SHUF2
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "line change and guidewire protective covering unraveled from metal wire".As a result, the device was removed and a new one was inserted.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The customer returned one nitinol guide wire for analysis.Definite evidence of use was observed.Visual analysis of the guide wire revealed that it was separated and unraveled from the distal weld.A separated coil wire was also returned.The distal weld was not returned for analysis.Microscopic examination confirmed the damage and confirmed that the proximal weld was present and spherical.The overall length of the guide wire core wire measured 603 which is within the specification limits of 600-608mm per the guide wire product drawing.The guide wire outer diameter (od) measured 0.79mm which is within the specification limits of 0.788-0.826mm per the guide wire product drawing.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which informs the user "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was advanced through a lab inventory ars/18ga introducer needle subassembly, and the guide wire passed with little to no resistance.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the customer report of a separated guide wire was confirmed through investigation of the returned sample.The guide wire was separated and unraveled at the distal weld.Despite this, the guide wire core wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.25 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Therefore, based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "line change and guidewire protective covering unraveled from metal wire".As a result, the device was removed and a new one was inserted.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19943201
• Report Number: 9680794-2024-00744
• Device Sequence Number: 7354396
• Product Code: FOZ
• UDI-Device Identifier: 10801902208368
• UDI-Public: (01)10801902208368(11)240108(17)250630(10)33F23L0686(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: ASK-42703-SHUF2
• Device Lot Number: 33F23L0686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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
• Patient Sex: Unknown