MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12122-F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "in the emergency room, the doctor found the swg unraveled during used on the patient." the user changed to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "in the emergency room, the doctor found the swg unraveled during used on the patient." the user changed to a new set.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire, one hemodialysis catheter, and the product lidstock for evaluation.Visual inspection of the guide wire revealed it was unraveled from the distal end.The core wire was broken adjacent to the distal weld.The coil wire was also separated into two distinct segments.Several kinks and bends were observed on the guide wire.Microscopic examination confirmed the damage.Both welds were present at the end of the coil wire and appeared full and spherical.The major kinks in the guide wire measured 232mm, 253mm, 259mm from the distal end.The broken core wire measured 597mm which is within the specifications of 596-604mm per product drawing; this indicates that no pieces of the core wire appear to be missing.The guide wire outer diameter measured 0.85mm, which is within the specifications of 0.838-0.877mm per product drawing.Functional inspection could not be performed due to the condition of the returned sample.A manual tug test confirmed the proximal weld was secure.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the 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 customer report of a separated guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed the guide wire was unraveled adjacent to the distal end, and the coil wire was separated into two segments.The returned guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.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 bs en iso 11070:2014 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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 19219836
• Report Number: 3006425876-2024-00380
• Device Sequence Number: 8106003
• Product Code: DQY
• UDI-Device Identifier: 00801902100108
• UDI-Public: 00801902100108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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
• Device Catalogue Number: CS-12122-F
• Device Lot Number: 71F22H1988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/05/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown