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

Catalog Number	CDA-45703-P1A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "when the catheter is opened and the metal guide is inserted, it is broken." additional information received from the customer states " the patient had to be punctured again.The guidewire was broken when it was inserted and access was not feasible.Only the physician performing the procedure can be fitted.Therefore, another catheter was opened and the patient was punctured again." the device was removed and replaced.There was no medical intervention required.The patient's current condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire for analysis.The catheter was not returned.The guidewire was unraveled, kinked, and showed evidence of use.Visual examination revealed the guidewire was unraveled from the distal weld and had multiple kinks in the guidewire body.The distal end of the core wire was broken and protruding out of the coil wire.The distal j-bend was misshapen but intact.Microscopic examination of the guidewire confirmed that the core wire was broken adjacent to the distal weld and that the weld was present at the end of the coil wire.Both welds appeared full and spherical.The major kinks in the guidewire body were measured at 219mm, 235mm, and 434mm from the proximal tip.The broken core wire measured 603mm in length, which is within the specification limits of 596mm - 604mm per guidewire product drawing; therefore , no pieces of the core wire appear to be missing.The outer diameter of the guidewire measured 0.81mm, which is within the specification limits of 0.788mm - 0.826 per guidewire product drawing.Functional inspection could not be performed for this complaint investigation due to the damage to the returned guidewire and without the catheter returned for analysis.A manual tug test confirmed that the proximal weld was intact.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 report that the guidewire was unraveled was confirmed through examination of the returned sample.The guidewire core wire was broken adjacent to 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.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guidewire 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 reported "when the catheter is opened and the metal guide is inserted, it is broken." additional information received from the customer states " the patient had to be punctured again.The guidewire was broken when it was inserted and access was not feasible.Only the physician performing the procedure can be fitted.Therefore, another catheter was opened and the patient was punctured again." the device was removed and replaced.There was no medical intervention required.The patient's current condition is reported as "stable".

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21838448
• Report Number: 9680794-2025-00338
• Device Sequence Number: 20821836
• Product Code: FOZ
• UDI-Device Identifier: 00801902099471
• UDI-Public: (01)00801902099471(11)240403(17)260102(10)33F24A1543(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 01/02/2026
• Device Catalogue Number: CDA-45703-P1A
• Device Lot Number: 33F24A1543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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