MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG AVALON BIOCAVAL DUAL LUMEN CATHETER, 31 FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 10031#AVALON ELITE

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested but not yet received.A follow-up medwatch will be submitted if additional information becomes available.

Event Description

According to the customer: "patient was on support with the same avalon cannula for 100 days.The metal coiling around the cannula punctured a hole in the cannula and blood was squirting out.She had to be changed to vv ecmo.The cannula is currently in pathology." (b)(4).

Manufacturer Narrative

(b)(4).The avalon cannula was returned to the factory and investigated in the decontamination / complaints laboratory.The cannula was delivery in a damaged condition to the laboratory.The cannula was found to be almost completely broken through, with only the wire and a small piece of tubing holding the cannula together.The customer's reported issue could be confirmed.The issue was referred to the responsible r&d engineer, who also discussed the complaint with the manufacturer, avalon.According to the evaluation by r&d and avalon, the cannula has been cut on the proximal side during the process of fixation with a suture during normal use.The instructions for use (ifu) g-158 (art.# 70106.3902, common device name: ifu: avalon elite, dual lumen cath.G-158, version 02) clearly states the following: item 5: instructions for use, subitem 5 "securing the device: the catheter should be secured to the patient around the rigid barbed connectors in manner that does not kink the catheter at the insertion site.Caution! a suture tied directly around the wire-reinforced section can cut, kink, or damage the catheter." the conclusion from the investigation that damage to the catheter was as a result of use not in accordance with the ifu.This is a user-caused, and not a product-related, issue.Based on the investigation and trending for this issue, a systemic issue is not indicated, therefore no further investigation or action is currently warranted for this issue in addition to continued periodic monitoring.

Event Description

Ref.: (b)(4).

• Brand Name: AVALON BIOCAVAL DUAL LUMEN CATHETER, 31 FR
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6000922
• MDR Text Key: 57186194
• Report Number: 8010762-2016-00611
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10031#AVALON ELITE
• Device Catalogue Number: 701063538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: 09/20/2016
• Supplement Dates FDA Received: 07/25/2017
• 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