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

Catalog Number	CDC-45703-XP1A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "we had a situation where the patient was getting a central line inserted and the guide wire broke during insertion.The doctor was able to obtain the guide wire and we received another central line kit and complete insertion of the central line." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and the product lidstock for evaluation.Visual inspection of the guide wire revealed it was unraveled from the proximal end.The core wire was broken adjacent to the proximal weld.The coil wire was also separated into two distinct segments.Several kinks and bends were observed on the guide wire.Microscopic examination confirmed the damage.Both welds were present at the end of the coil wire and appeared full and spherical.The major kinks in the guide wire measured 349mm and 370mm from the distal end.The broken core wire measured 596mm which is within the specifications of 596-604mm per product drawing; this indicates that no pieces of the core wire appear to be missing.The guide wire outer diameter (od) measured 0.790mm, which is within the specifications of 0.788-0.826mm per product drawing.Functional inspection could not be performed due to the condition of the returned sample.A manual tug test confirmed the distal weld was secure.A device history record review was performed , and no relevant findings were identified.The ifu provided with this kit informs the user, "warning: do not apply undue force on guidewire to reduce risk of possible breakage".The customer report of a separated guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed the guide wire was unraveled separated adjacent to the proximal weld , and the coil wire was separated into two segments.The returned guide 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 2.75 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.Based on these circumstances, unintentional use error 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 "we had a situation where the patient was getting a central line inserted and the guide wire broke during insertion.The doctor was able to obtain the guide wire and we received another central line kit and complete insertion of the central line".No patient harm or injury.No medical intervention required.The patient's current condition is reported as "stable".

• Brand Name: ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB
• 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: 19279924
• Report Number: 9680794-2024-00435
• Device Sequence Number: 18040565
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: 20801902117216
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 05/31/2025
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 33F23J0722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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