MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25122-F

Device Problems Material Separation (1562); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the guide wire (swg) is about to break".The user changed to a new set.No patient injury or consequence reported.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the guide wire (swg) is about to break".The user changed to a new set.No patient injury or consequence reported.The patient's current condition is reported as "fine".Additional information: 12march the swg got stuck when attempting to insert through ars and could not be retracted.The whole set was removed, and the wire was found to be broken.All components were removed from the patient.

Manufacturer Narrative

(b)(4).New information received indicates that this was not a reportable event, thus, the initial mdr submitted on 22 jan 2024 should be retracted.

Event Description

It was reported "the guide wire (swg) is about to break".The user changed to a new set.No patient injury or consequence reported.The patient's current condition is reported as "fine".

Event Description

It was reported "the guide wire (swg) is about to break".The user changed to a new set.No patient injury or consequence reported.The patient's current condition is reported as "fine".Additional information: 12march the swg got stuck when attempting to insert through ars and could not be retracted.The whole set was removed, and the wire was found to be broken.All components were removed from the patient.

Manufacturer Narrative

(b)(4), the customer returned a single guide wire assembly for evaluation.Signs of use were observed on the guide wire body.The arrow raulerson syringe (ars) involved with this complaint was not returned.The guide wire was observed to have two major kinks across the body.The distal j-bend was slightly misshapen but intact.One kink was located directly adjacent to the distal j-bend, which resulted in the distal j-bend to be misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.Visual analysis could not be performed on the ars involved with this complaint as it was not returned.The kinks on the guide wire measured 295mm and 666mm from the proximal weld.The guide wire length measured 683mm, which is within the specification limits of 679mm-687mm per the guide wire product drawing.The guide wire outer diameter measured 0.850mm, which is not within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The discrepancy with the guide wire outer diameter indicates that either the incorrect sample was returned or the incorrect finished good material#/lot# was reported by the customer.The returned guide wire was inserted through a lab inventory ars/introducer needle assembly.Minor resistance was encountered at the kinking; however, the guide wire was able to pass completely through the ars.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".Functional inspection of the actual ars could not be performed as it was not returned for analysis.A manual tug test confirmed that the distal and proximal welds were secure and intact.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 excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed two major kinks across the body.This kinking created resistance when being inserted through a lab inventory ars/introducer needle subassembly.Further dimensional analysis revealed that the guide wire outer diameter measured outside of specification.A device history record review was performed with no relevant findings.The appearance of the kinking is consistent with damage due to undue force applied during insertion; however, the root cause cannot be confirmed without the ars also returned for analysis.Likewise , due to the dimensional discrepancy, it cannot be confirmed if the customer returned the incorrect guide wire or if the incorrect finished good was reported.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• 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: 18558324
• MDR Text Key: 333451193
• Report Number: 3006425876-2024-00060
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: 00801902100207
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2024

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-25122-F
• Device Lot Number: 71F23C2067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 01/04/2024; 02/22/2024; 03/14/2024
• Supplement Dates FDA Received: 02/06/2024; 03/14/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED; NONE REPORTED