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 Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the swg was found separated during used on the patient".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the swg was found separated during used on the patient".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).The report that the guide wire unravelled was confirmed through examination of the returned sample.The customer returned an opened cvc kit containing a guide wire.No obvious signs-of-use were observed.Visual examination revealed the guide wire is unravelled from the proximal weld and contains two additional kinks towards the distal end.The kinking and the unravelling resulted in the distal j-bend to be misshapen.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.Both welds were present and appeared full and spherical.The kinks on the guide wire measured 15mm and 68mm via calibrated ruler from the distal weld.The guide wire length from the distal weld to the point of separation on the core wire measured 600mm via calibrated ruler, which was within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.850mm via calibrated caliper, which was within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.Functional inspection could not be performed due to the severity of the damage on the returned guide wire.A manual tug test confirmed that the distal weld was intact.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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.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 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 desi gn 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.Other remarks: n/a; corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi #.Udi related data quality updates only.
Event or Problem Description
It was reported that "the swg was found separated during used on the patient".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18401687
• Report Number: 3006425876-2023-01284
• Device Sequence Number: 11795635
• Product Code: DQY
• UDI-Device Identifier: 00801902100108
• UDI-Public: (01)00801902100108(11)211122(17)261031(10)71F21L1368(21)
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

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 Catalogue Number: CS-12122-F
• Device Lot Number: 71F21L1368
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 01/19/2024; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/22/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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
• Patient Sex: Unknown