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	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that guide wire bent.So md opend up the new kit to finish the procedure.
Additional Manufacturer Narrative
Qn# (b)(4) the report that the spring wire guide was kinked was confirmed through examination of the returned sample.The customer returned one opened cvc kit, including one guide wire assembly, catheter, and dilator, for evaluation.The end cap and straightener tubing, which are components of the guide wire assembly, were returned but not attached to the assembly.No definite signs of use were observed.Visual analysis revealed that the guide wire contained one kink along the body.Microscopic examination confirmed the damage.The kink on the guide wire would have been protected during packaging, shipping, and storage.Both welds were observed to be full and spherical.No other defects or anomalies were observed with the guide wire, tubing, nor the returned tray.The kink in the guide wire measured 345mm (ruler: ref-003101) form the proximal end.The overall length of the guide wire measured 454mm via calibrated ruler, which was within the specifications of 450-458mm per product drawing.The guide wire outer diameter (od) measured 0.792mm via calibra ted micrometer, which was within the specifications of 0.788-0.826mm per product drawing.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, " advance guidewire into arrow raulerson syringe ap proximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was advanced through a lab inventory ars/ 18ga needle subassembly and was able to pass with little to no resistance.The catheter was also advanced over the guide wire, and little to no resistance was experienced.A manual tug test confirmed both welds were intact.A device history record review was performed, and no relevant findings were identified.During normal assembly, the kinked portion of the guidewire are protected within the protective tubing of the advancer assembly, however, the end cap and straightener tube were missing from the assembly.Based on the customer report and sample received, the potential root cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that guide wire bent.So md opend up the new kit to finish the procedure.
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that guide wire bent.So md opend up the new kit to finish the procedure.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (b)(4).

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18245081
• Report Number: 3006425876-2023-01153
• Device Sequence Number: 7116717
• Product Code: FOZ
• UDI-Device Identifier: 00801902102218
• UDI-Public: (01)00801902102218(11)221103(17)241031(10)71F22K2884(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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: 10/31/2024
• Device Catalogue Number: CS-22703-E
• Device Lot Number: 71F22K2884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/20/2023; Not provided
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/22/2023; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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; NOT REPORTED
• Patient Sex: Unknown