MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25122-F

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the swg (spring wire guide) is kinked and unable to insert into the catheter.

Event Description

The customer reports that the swg (spring wire guide) is kinked and unable to insert into the catheter.

Manufacturer Narrative

(b)(4).The customer returned a single spring wire guide (swg) and lidstock for evaluation.The guide wire was observed to have two kinks inside the body.The distal j-bend was misshapen intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The kinks in the guide wire were located 212mm and 245mm from the distal end.The overall length of the guide wire measured 685mm which is within the specification of 678-688mm per guide wire product drawing.The outer diameter of the guide wire measured 0.841mm which is within the specification of 0.838-877mm per guide wire product drawing.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components only encountering resistance at the kinks.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with the 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 report that the guide wire was kinked was confirmed through examination of the returned sample.The guide wire body had two kinks inside the body.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Based on these circumstances, unintentional use error likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.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 INC.; reading PA
• MDR Report Key: 9853539
• MDR Text Key: 184270593
• Report Number: 3006425876-2020-00250
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2021
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F19E0846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1