MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN001348

Device Problems Deformation Due to Compressive Stress (2889); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The customer provided one x-ray photo of the sample for inspection.Visual inspection of the photo confirmed that the catheter had kinked while in the patient.According to amrq-000075 rev 15 "the catheter body extrusion shall have a corrected kink radius of = 2.5 cm when tested at ambient indoor conditions." this means that the catheter should not kink unless its bend radius is less than or equal to 2.5 cm.Based on the photo, it cannot be determined if the catheter was bent to form a radius less than 2.5 cm.A complete visual inspection could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "do not create a sharp bend in catheter tunnel; kinking and reduced flow will result.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 ifu also instructs the user, "perform a small blunt dissection at venotomy toward exit site (this will minimize catheter kinking at venous insertion site)." the complaint of a catheter kinking in use was confirmed by the customer photo.Complete complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on sales history, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The physician placed a 19cm vector flow catheter (cs-15192-vfe) to a patient on (b)(6)2020 (vein puncture is done under echo and placement verification by x-ray).The verification image shows a "plicature/kink" of the catheter.During the dialysis, the department reports that the catheter does not work (no flow).The physician replaced the catheter on (b)(6) 2020 with a new vector flow 19cm (same technique).The second catheter also showed a kink on the x-ray.Once again, the dialysis department reports that the catheter is not working (still no flow).They decided to replace the catheter one last time with a different product and dialysis could be performed.No patient injury or complication reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 10817956
• MDR Text Key: 217097363
• Report Number: 9680794-2020-00447
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: IPN001348
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F19G0160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2019
• 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
• Patient Outcome(s): Required Intervention