MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW-CLARK VECTORFLOW HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN001356

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the hub is leaking.The device was replaced, and the issue was resolved.

Manufacturer Narrative

Qn# (b)(4).The sample was not returned; however, the customer provided one photo and video for evaluation.The photo showed a leak near the extension line/juncture hub area.The leak was confirmed by the customer video.However, without the returned device, visual inspection cannot be completed.A device history record review was performed and no relevant findings were identified.The 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." the report that the juncture hub leaked was confirmed through examination of the customer supplied photo and video.The image and vi deo showed the leaking; however, the actual complaint sample was not returned for evaluation.The device history review was completed with no evidence to suggest a manufacturing related cause.The probable cause of the leaking could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the hub is leaking.The device was replaced, and the issue was resolved.

• Brand Name: ARROW-CLARK VECTORFLOW HEMODIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9322806
• MDR Text Key: 177796100
• Report Number: 9680794-2019-00470
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K141051
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: IPN001356
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 13F19E0258
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1