MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22703-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that guide wire bent and kinked.So md opened up the new kit to finish the procedure".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The customer returned one, opened cvc kit and lidstock for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.The guide wire was observed to have one kink adjacent to the distal j-bend.The distal j-bend was slightly misshapen but intact.Microscopic examination confirmed the kink on the guide wire body.Both welds were present and were observed to be full and spherical.The kinks in the guide wire were located 398mm via calibrated ruler from the proximal tip.The overall length of the guide wire measured 456mm via calibrated ruler, which was within the specification of 450mm-458mm per guide wire product drawing.The outer diameter (od) of the guide wire measured 0.80mm via calibrated caliper, which was within the specification of 0.788mm-0.826mm per guide wire product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was advanced through the returned ars/18ga introducer needle subassembly to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that the distal and proximal welds were secure and intact.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".A device history record review was performed, and no relevant findings were identified.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a; corrected data: n/a.
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that guide wire bent and kinked.So md opened up the new kit to finish the procedure".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that guide wire bent and kinked.So, md opened up the new kit to finish the procedure".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn #(b)(4).Udi related data quality updates only section d.4.-unique identifier (udi)# corrected to (b)(4).Other remarks: n/a.Corrected data: n/a.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18410942
• Report Number: 3006425876-2023-01289
• Device Sequence Number: 8723530
• Product Code: FOZ
• UDI-Device Identifier: 00801902102218
• UDI-Public: (01)00801902102218(11)230420(17)250328(10)71F23D0754(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2025
• Device Catalogue Number: CS-22703-E
• Device Lot Number: 71F23D0754
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/24/2024; Not provided
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/25/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.
• Patient Sex: Unknown