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

(b)(4).The customer returned one connector assembly for evaluation.Visual examination revealed both extension lines contained small holes adjacent to the juncture hub.The outer diameters of the two extension lines measured to be 0.189" and 0.190" which is within specifications of 0.185-0.191" per product drawing.The inner diameters of the two extension lines measured to be 0.120" and 0.125" which are within specifications of 0.120-0.126" per product drawing.This indicates that the wall thicknesses were within specifications.A lab inventory syringe was used to flush both extension lines.Leaks were detected adjacent to the juncture hub when each was flushed.A manual tug test confirmed the extension lines were fully secured within the juncture hub.A device history record review was performed with no relevant findings.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 customer report of a leaking extension line/juncture hub was confirmed by complaint investigation.The extension lines contained small holes adjacent to the juncture hub.A device history record review was performed with no relevant findings and the sample passed all relevant dimensional inspection.Based on the sample received, manufacturing (assembly) caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.

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: 9321779
• MDR Text Key: 177795901
• Report Number: 9680794-2019-00465
• 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 an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1