MAUDE Adverse Event Report: ANGIOTECH HEMOSTREAM DIALYSIS CATHETER

Device Problems Structural Problem (2506); Infusion or Flow Problem (2964)

Patient Problems Hemorrhage/Bleeding (1888); Overdose (1988)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

Diagnosis or reason for use: hemodialysis access.Life saving complaint.I want to post a complaint about hemostream dialysis catheter made by angiotech, because it has wrong design they may put patient's life at risk.The catheter mentioned above has a triple arterial lumen of which one clamp is controlling the three lumens, with one outlet.In case of occlusion (thrombosis) of one or two of these lumens and during giving the heparin lock at the end of dialysis the heparin will flow only through the patent lumen which ahs 1/3 of the size while we give amount enough to fill all the lumens.So the heparin lock will reach the blood stream in high amount (1/3 or 2/3 of the heparin lock will reach the blood stream depending on how many lumen are thrombosed 1 or 2).This is based on our experience with one hemodialysis patient.This patient was developing epistaxis, hematemesis and or melena many times at the day of dialysis.Patient a ptt was checked pre dialysis and 30 min before ending, results were in range, so a peripheral post dialysis sample was taken revealing very high aptt (more than 180 sec), so the heparin lock was suspected and investigated, revealing that the patient has thrombosed 2 lumens of his triple arterial lumen catheter, so heparin is going through one patent lumen only which will not compensate the whole amount of heparin, then 2/3 of heparin lock will reach blood stream, raising the patient aptt and increasing his bleeding tendency causing his epistaxis, hematemesis and melena.We started to give his heparin lock for the arterial lumen divided in three doses, every lumen is injected while clamping the other 2 lumens, with normal aptt results.Thank you.

• Brand Name: HEMOSTREAM DIALYSIS CATHETER
• Type of Device: HEMOSTREAM DIALYSIS CATHETER
• Manufacturer (Section D): ANGIOTECH
• MDR Report Key: 4226597
• MDR Text Key: 20756038
• Report Number: MW5038936
• Device Sequence Number: 1
• Product Code: MSD
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISORDIL: 10 MG BD; CACO3 TAB: TID; AMLODIPINE: 5 MG OD; RENAGEL: 800 MG TID; ASPIRIN: 81 MG OD; PLAVIX: 75 MG OD; COVERSYL: 5 MG OD
• Patient Age: 32 YR
• Patient Weight: 70