MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-45703-PFLH2
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was initially reported "during line placement, the doctor experienced difficulty with the guidewire kinking and it subsequently broke off while attempting to retract it".Additional information reports "guidewire outside (spring looking) broke inside the dilator, both the dilator and the guidewire came out, as it got stuck at the tip." subsequent information provided states "no piece was left in the patient, as the inner thread was intact." the operator placed a new line.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire for evaluation.The catheter was not returned.The guide wire showed evidence of use in the form of biological material.Visual examination revealed the guide wire is unraveled from the proximal weld and contained one major kink.Microscopic examination confirmed that the core wire was broken adjacent to the proximal weld and that the weld was present at the end of the coil wire.Both welds appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The kink on the guide wire measured 390mm from the proximal end of the core wire.The broken core wire measured 600mm in length, which is within the specification of 596mm-604mm per guide wire product drawing.Therefore, no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.788mm, which is within the outer diameter specification of 0.788mm-0.826mm per guide wire product drawing.Functional inspection of the guide wire could not be performed for this complaint investigation due to the severity of the damage.A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the proximal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.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.Based on these circumstances, unintentional use error likely contributed to this event; however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was initially reported "during line placement, the doctor experienced difficulty with the guidewire kinking and it subsequently broke off while attempting to retract it".Additional information reports "guidewire outside (spring looking) broke inside the dilator, both the dilator and the guidewire came out, as it got stuck at the tip." subsequent information provided states "no piece was left in the patient, as the inner thread was intact." the operator placed a new line.The patient's current condition is reported as "unknown".

• Brand Name: ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20521888
• Report Number: 9680794-2024-01049
• Device Sequence Number: 7969756
• Product Code: FOZ
• UDI-Device Identifier: 10801902139952
• UDI-Public: (01)10801902139952(11)240404(17)251031(10)33F24B0765(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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 10/31/2025
• Device Catalogue Number: ASK-45703-PFLH2
• Device Lot Number: 33F24B0765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown