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

Catalog Number	CDA-42703-P1A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on the weekend, we had to put a central line in someone and the guide wire in two of the packs were kinked, one was kinked while inside the patient and the whole thing needed to be removed in order to get it out and they had to go to a different site all together." the patient's current condition is reported as "fine".Associated mdr number: 9680794-2024-00792.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and product lidstock for analysis.No definite signs of use were observed.Visual analysis of the guide wire revealed one kink/bend towards the distal j-bend.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kink on the guide wire measured 415mm from the proximal weld.The guide wire length measured 455mm, which is within the specification limits of 450-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.79mm, which is within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The guide wire was passed through a lab inventory arrow raulerson syringe (ars)/18ga introducer needle subassembly.Little to no resistance was encountered as the guide wire passed completely through the assembly.Performed per ifu statement , "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." a manual tug test confirmed that the distal and proximal welds were secure and 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 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 of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked towards the distal j-bend.Despite the damage, the sample met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Therefore based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "on the weekend, we had to put a central line in someone and the guide wire in two of the packs were kinked, one was kinked while inside the patient and the whole thing needed to be removed in order to get it out and they had to go to a different site all together." the patient's current condition is reported as "fine".Associated mdr number: 9680794-2024-00792.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 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: 20001044
• Report Number: 9680794-2024-00794
• Device Sequence Number: 4877832
• Product Code: FOZ
• UDI-Device Identifier: 00801902099440
• UDI-Public: (01)00801902099440(11)240404(17)260108(10)33F24C0086(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: 01/08/2026
• Device Catalogue Number: CDA-42703-P1A
• Device Lot Number: 33F24C0086
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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
• Outcome Attributed to Adverse Event: Congenital Anomaly
• Patient Sex: Unknown