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 Material Separation (1562); Unraveled Material (1664)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

It was reported the spring wire guide was stuck when the physician tried to remove it from the vessel.The wire was broken and the broken wire almost slipped back into the vessel, but was clamped with a kelly clamp and removed.The guidewire was removed in its entirety.A new catheter set was used to complete hemodialysis.No patient harm reported.

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the spring wire guide was stuck when the physician tried to remove it from the vessel.The wire was broken and the broken wire almost slipped back into the vessel, but was clamped with a kelly clamp and removed.The guidewire was removed in its entirety.A new catheter set was used to complete hemodialysis.No patient harm reported.

Manufacturer Narrative

(b)(4).The customer returned two guide wires for evaluation.One guide wire appeared separated and unraveled , and the second guide wire appeared kinked.The customer indicated to only investigate the separated guide wire and disregard the second guide wire returned.Signs of use were observed on the returned components.Visual inspection of the guide wire revealed several kinks throughout its body.The guide wire appeared unraveled and separated from the distal end.The coil wire separated into two pieces.The guide wire was also unraveled from the proximal end.Microscopic examination confirmed the damage.The core wire separated adjacent to both the distal and proximal welds.Both welds were present at the ends of the coil wire.The major kinks in the guide wire measured 120mm, 300mm, and 525mm from the distal end.The core wire total length measured 600mm, which is within the specifications of 596-604mm per product drawing.This indicates that no portions of the core wire were missing.The guide wire outer diameter measured 0.84mm , which is within the specifications of 0.838-0.877mm per product drawing.Functional inspection of the guide wire could not be performed due to the damage.A device history record review was performed with no relevant findings.The instructions-for-use (ifu) provided with this 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.The returned guide wire was observed to be separated and unraveled from the distal end, as well as unraveled from the proximal end.The guide wire met all dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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
• 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: 16807708
• MDR Text Key: 313929749
• Report Number: 3006425876-2023-00407
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K862056
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-12122-F
• Device Lot Number: 71F22A2616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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; NOT REPORTED