MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15242-VSP

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: (b)(6) 2023, the swg was found kinked prior to use.There was no patient involvement.

Event Description

It was reported that: (b)(6) 2023, the swg was found kinked prior to use.There was no patient involvement.

Manufacturer Narrative

(b)(4).The customer returned one guide wire assembly for analysis.It was noted that the guide wire was extended out of the straightener tube and the end cap ((b)(4)) was not returned with the sample.No definite signs of use were observed.Visual analysis revealed that the returned guide wire was kinked towards the distal end.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.A lab inventory cap was assembled to the returned device.During normal assembly, the location of the kinking would be located within the straightener tube, protecting it from damage.Comparison of the returned assembly and individual guide wire component with the product drawings revealed that the returned sample assembly is not the same guide wire normally packaged within the reported finished good.Further dimensional analysis of the returned guide wire revealed that both the length and outer diameter are outside the specification limits.Based on this, it is unknown if the customer returned the wrong device, or if they reported the wrong finished good.The kink on the guide wire measured 32mm from the distal weld.The guide wire total length measured 68.4cm, which is not within the specification limits of 98.75cm-101.25cm per the guide wire product drawing.The guide wire outer diameter measured 0.0335", which is not within the specification limits of 0.0370"-0.0385".The discrepancy with the guide wire length and outer diameter indicates that the customer either returned the incorrect device or reported the incorrect part number.The returned swg was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "advance swg in routine fashion to desired depth".The undamaged portions of the wire passed through a lab inventory introducer needle with little to no issue.A manual tug test confirmed the distal and proximal welds were secure.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a guide wire kinking was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was kinked; however, during normal assembly, the kinked area would be protected by the straightener tube from the advancer assembly.The end cap, which was not returned, functions to keep the guidewire contained within the advancer assembly.Further dimensional analysis revealed that the individual guide wire and full guide wire assembly are not the same components normally packaged within the reported finished good.Despite this, the sample met all relevant functional testing, and a device history record review of the reported batch did not reveal any relevant findings.Based on the customer report and the sample received, the root cause cannot be determined based on the dimensional discrepancy between the returned device and the reported part number.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• 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: 18129118
• MDR Text Key: 327995094
• Report Number: 9680794-2023-00872
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: 00801902096333
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

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
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 13F22L0602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED