MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAP

Catalog Number	CDA-42703-P1A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the guide wire uncoiled while inside the patient during insertion.The md was able to retract it, with some difficulty.Xrays completed afterwards showed the guidewire was completely removed, and the new line was in good placement.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken 7mm from the distal 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 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.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: the guide wire uncoiled while inside the patient during insertion.The md was able to retract it, with some difficulty.Xrays completed afterwards showed the guidewire was completely removed, and the new line was in good placement.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18333850
• Report Number: 9680794-2023-01006
• Device Sequence Number: 8489729
• Product Code: FOZ
• UDI-Device Identifier: 00801902099440
• UDI-Public: 00801902099440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 04/18/2025
• Device Catalogue Number: CDA-42703-P1A
• Device Lot Number: 33F23F0313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown