MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS. IMPLANTED

Catalog Number CS-15282-VSP

Device Problems Cut In Material (2454); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was received by the manufacturer, but the investigation is in progress at the time of this report.

Event Description

The customer alleges that the device failed and the surgeon removed the device.There is no report of patient injury or consequence.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one used c-21523-045 catheter.Upon visual inspection it was noticed that the catheter body had a cut in it.This was likely caused by contact with a sharp object due to the smoothness of the cut surfaces.The arterial split portion of the catheter was measured to be 5.9 cm, the body of the catheter measured 25.1 cm from the end of the venous portion of the catheter, and the difference in the length of the venous and arterial portions was measured to be 2.7 cm.All dimensions were within specification.A device history record review was performed and no relevant findings were identified.The customer reported issue of the catheter being cut was confirmed during sample investigation.During visual inspection a cut was found on the catheter body that was characteristic of those created by a sharp object.The probable cause of this issue is operational context.

Event Description

The customer alleges that the device failed and the surgeon removed the device.There is no report of patient injury or consequence.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Type of Device: CATHETER, HEMODIALYSIS. IMPLANTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6694410
• MDR Text Key: 79353924
• Report Number: 1036844-2017-00279
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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