MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number IPN919796

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "acute dialysis catheter being placed.Guide wire threaded.Resistance felt at 20cm marking.Needle attempted to be withdrawn over guidewire, became stuck.Unable to withdraw needle.Needle and wire removed together and vascath resited on other side.Video available of faulty device." there was no reported patient harm.Reported as fine post procedure.

Event Description

It was reported that "acute dialysis catheter being placed.Guide wire threaded.Resistance felt at 20cm marking.Needle attempted to be withdrawn over guidewire, became stuck.Unable to withdraw needle.Needle and wire removed together and vascath resited on other side.Video available of faulty device." there was no reported patient harm.Reported as fine post procedure.

Manufacturer Narrative

(b)(4).The customer report of guide wire needle resistance was confirmed by visual inspection of the customer supplied video and investigation of the returned sample.The video revealed that the guide wire could not be easily threaded through the cannula.It was also noted that the guide wire appeared to be kinked directly adjacent to the needle bevel.Large quantities of congealed biological material were also observed exiting the cannula, which likely caused or contributed to the resistance reported.Visual analysis of the returned one guide wire assembly confirmed that it was unravelled from the distal end.Definite signs of use are observed.The guide wire also contained multiple kinks along the body.The distal j-bend is misshapen but intact.Microscopic examination confirmed the damage and revealed that both welds are full and spherical.Visual inspection of the introducer needle could not be performed as it was not returned for analysis.The kinks in the guide wire measured 25mm, 454mm, and 695mm from the proximal tip and the overall length of the guide wire core wire measured 700mm via calibrated ruler which is within the specification limits of 694mm - 706mm per the guide wire product drawing.The outer diameter (od) of the guide wire measured 0.942mm via calibrated micrometer which is within the specification limits of 0.94mm - 0.965mm per the guide wire product drawing.Functional inspection of the guide wire could not be performed due to the damage.A manual tug test confirmed that the proximal weld is secure and intact.Additionally, 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 ifu also states, "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 the investigation.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 c ontributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 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: 17124810
• MDR Text Key: 317128677
• Report Number: 3006425876-2023-00611
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

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 Model Number: IPN919796
• Device Catalogue Number: CS-25142-F
• Device Lot Number: 71F22F5501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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.