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

Catalog Number CS-12122-F

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

It was reported "the dilator was found blocked during used on the patient." no medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer returned one, opened hemodialysis kit for analysis.Signs-of-use in the form of biological material was observed.The dilator length measured 5 1/2", which is within the specification limits of 5 1/4"-5 3/4.The dilator outer diameter measured 4.00mm, which is within the specification limits of 3.97mm-4.The guide wire inner diameter at the proximal end measured 1.4224mm, which is within the specification limits of 1.40mm-1.47mm.The returned guide wire was inserted through the proximal end of the dilator.Major resistance was encountered when the guide wire reached the tip, which prevented the guide wire from passing.Slight force was applied, and the guide wire was able to pass through the damaged tip.No resistance was encountered from any other location within the dilator body.Additional testing was not required as part of this complaint investigation.All complaints are trended across product families on a monthly basis.Therefore, a separate complaint history review is not required.A device history record review was performed, and no relevant findings were identified.Corrective action is not required as part of this complaint investigation unintentional user error likely caused or contributed to this event.The report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the tip was split and frayed.White stress marks were also observed around the damage.This damage created resistance when inserting the guide wire.Despite the damage, the dilator met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the dilator was found blocked during used on the patient." no medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer returned one, opened hemodialysis kit for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the dilator tip was split/frayed.This resulted in the tip to bend and become partially occluded.Microscopic examination confirmed the damage and revealed white stress marks around the damage.Biological material was also observed inside the tip indicating the device came in contact with the patient.The dilator length measured 5 1/2", which is within the specification limits of 5 1/4" - 5 3/4" per the dilator product drawing.The dilator outer diameter measured 4.00mm, which is within the specification limits of 3.97mm-4.06mm per the dilator extrusion product drawing.The guide wire inner diameter at the proximal end measured 1.4224mm , which is within the specification limits of 1.40mm-1.47mm per the dilator extrusion product drawing.The returned guide wire was inserted through the proximal end of the dilator.Major resistance was encountered when the guide wire reached the tip, which prevented the guide wire from passing.Slight force was applied, and the guide wire was able to pass through the damaged tip.No resistance was encountered from any other location within the dilator body.Performed per ifu statement , "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".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 damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the tip was split and frayed.White stress marks were also observed around the damage.This damage created resistance when inserting the guide wire.Despite the damage, the dilator met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error likely 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
• Type of Device: 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: 18806676
• MDR Text Key: 336625303
• Report Number: 3006425876-2024-00265
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-12122-F
• Device Lot Number: 71F22A0763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• 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: NONE REPORTED.; NONE REPORTED.