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

Catalog Number CS-15232-VFIE

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "instrumental thrombosis and clotting in 48 hours of insertion".A new catheter was inserted, no other intervention reported.No report of patient injury or complication.The patient's condition is reported as fine.

Event Description

The complaint is reported as: "instrumental thrombosis and clotting in 48 hours of insertion" a new catheter was inserted, no other intervention reported.No report of patient injury or complication.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer supplied five photos for evaluation.The photos displayed the distal end of a catheter body.A significant amount of biological material (tissue, coagulated blood, etc.) was present on the catheter.The customer returned one hemodialysis catheter for evaluation.The catheter appeared to be thoroughly cleaned prior to being returned for analysis as no signs of use were detected on the sample.Visual examination did not reveal any defects or anomalies.The returned catheter was flushed using a water-filled lab inventory syringe.No blockages or leaks were detected.A device history record review was performed with no relevant findings.The ifu provided with this kit states, "the arrow-clark vectorflow antegrade catheter is intended for long-term hemodialysis vascular access only and should not be used for any other purpose other than those indicated herein.Do not use this catheter in patients with thrombosed vessels." the ifu also instructs, "establish and maintain catheter patency.Solution and frequency of flushing a venous access catheter should be established in hospital/institutional policy." the customer report of a catheter thrombosis was confirmed by visual examination of the customer supplied photos.The returned sample passed all relevant visual and functional testing, and a device history record review was performed with no relevant findings.Based on the customer report and photos provided, the patient condition likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11307073
• MDR Text Key: 231156848
• Report Number: 9680794-2021-00045
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: CS-15232-VFIE
• Device Lot Number: 13F19H0335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1