MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB; CATHETER HEMODIALYSIS NON IMPL

Catalog Number CDC-25142-1A

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the user placed the line, met little resistance and when they pulled the guidewire out, it was coiled.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The report that the guide wire unravelled was confirmed through examination of the returned sample.The customer provided one image showing a guide wire.Visual analysis revealed that the guide wire was unravelled from the distal end.The customer returned one guide wire for analysis.Signs-of-use in the form of biological material was observed.Visual analysis revealed that the guide wire was unravelled towards the distal end.Microscopic examination confirmed the damage and revealed that the core wire had separated directly adjacent to the distal weld.It was also noted that the distal and proximal welds were spherical and intact; however, the distal j-bend was observed to be misshapen.The guide wire length from the proximal weld to the distal end of the core wire measured 603mm via calibrated ruler, which was within the specification of 596mm-604mm per guide wire product drawing; therefore, no piece of the core wire appeared to be missing.The outside diameter (od) of the guide wire measured.840mm via calibrated caliper which was within the od specification of 0.0838mm-0.877mm per guide wire product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The undamaged end (proximal end) of returned guide wire was inserted through a lab inventory arrow raulerson syringe (ars) and 18ga introducer needle subassembly.Little to no resistance was observed as the guide wire passed through the subassembly.A manual tug test confirmed that the proximal weld was intact.The ifu provided with the kit informs 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".A device history record review was performed, and no relevant findings were identified.No manufacturing defects were found during this investigation.Arrow guide wires of this size were designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy might present a tortuous path that could contribute to the possibility of guide wire kinking.Gu ide wire breakage might occur if a force greater than the design specification was 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.

Event Description

It was reported the user placed the line, met little resistance and when they pulled the guidewire out, it was coiled.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB
• Type of Device: CATHETER HEMODIALYSIS NON IMPL
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17390714
• MDR Text Key: 319707774
• Report Number: 9680794-2023-00522
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 50801902123584
• UDI-Public: 50801902123584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

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 Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Catalogue Number: CDC-25142-1A
• Device Lot Number: 33F23B0154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Male