MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAP

Catalog Number	CDC-15703-P1A
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "rapid response was called by med surg.Dr.Responded from ed, who attempted to insert central line, he was unable to do so because of guidewire failure, it came uncoiled and unthreaded.There were 2 unsuccessful attempts for inserting central line, at right ij and right femoral, same issue happened twice." additional information received from the physician states ".I held off on attempting another placement of the central line since the patient did have 2 peripheral ivs and a io." there was no patient harm or injury but the team was unable to get cvc line access in the patient.No medical intervention required.The patient's current condition is reported as "in critical condition".Associated mdr numbers include: 9680794-2025-00377.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the actual device was not returned; however, the customer provided one photo for analysis.The image shows an unraveled guidewire with evidence of use.The complaint of an uncoiled guidewire was able to be confirmed by the photo, however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.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, "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 customer report of an unraveled guidewire was confirmed by visual inspection of the customer supplied photo.The provided image shows a guidewire with evidence of unraveling, however, full complaint verification testing to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Arrow guidewires 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 guidewire kinking.Guidewire breakage may occur if a force greater than the design specification is applied during removal.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "rapid response was called by med surg.Dr.Responded from ed, who attempted to insert central line, he was unable to do so because of guidewire failure, it came uncoiled and unthreaded.There were 2 unsuccessful attempts for inserting central line, at right ij and right femoral, same issue happened twice." additional information receieved from the physician states ".I held off on attempting another placement of the central line since the patient did have 2 peripheral ivs and a io." there was no patient harm or injury but the team was unable to get cvc line access in the patient.No medical intervention required.The patient's current condition is reported as "in critical condition".Associated mdr numbers include: 9680794-2025-00376 and 9680794-2025-00377.

• Brand Name: ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM
• 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: 21967557
• Report Number: 9680794-2025-00376
• Device Sequence Number: 12865505
• Product Code: FOZ
• UDI-Device Identifier: 10801902116793
• UDI-Public: (01)10801902116793(11)240708(17)260630(10)33F24D0980(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2025

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: 06/30/2026
• Device Catalogue Number: CDC-15703-P1A
• Device Lot Number: 33F24D0980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown