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 Problem Unraveled Material (1664)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: swg unraveled.[during use on a patient, the swg became detached and bifurcated during the removal of the wire, no patient harm].

Event Description

It was reported that: swg unraveled.[during use on a patient, the swg became detached and bifurcated during the removal of the wire, no patient harm].

Manufacturer Narrative

Qn# (b)(4).The report that the guide wire unravelled and kinked was confirmed through examination of the returned sample.The customer returned one guide wire for analysis.No obvious signs-of-use were observed.Visual examination revealed the guide wire was unravelled at the distal end with multiple kinks along the body.The distal end of the core wire was protruding out of the coil wire.The distal j-bend was misshapen and still intact.Microscopic examination of the guide wire confirmed the core wire was broken at the distal weld.Both welds appeared full and spherical.The kinks on the guide wire measured 376mm, 405mm, and 669mm via calibrated ruler from the proximal end.The broken core wire measured 685mm in length via calibrated ruler, which was within the specification of 678-688mm per guide wire product drawing; therefore, no pieces of the core wire appeared to be missing.The outer diameter (od) of the guide wire measured 0.850mm via calibrated micrometer which was within the specification of 0.838-0.877mm per guide wire product drawing.Functional inspection could not be performed due to the condition of the returned sample.A manual tug test confirmed that the proximal weld was intact.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." a device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.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 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18382589
• MDR Text Key: 331482840
• Report Number: 3006425876-2023-01274
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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-25122-F
• Device Lot Number: 71F23C0406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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.