MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG AVALON ELITE VASCULAR ACCESS KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

September 29, 2015 08:10 am (gmt-4:00) added by (b)(6): (b)(4).Maquet cardiopulmonary (b)(4) does not know which guidewire is exactly involved.Further information about the incident and the guidewire device in question is already requested.Based on the information about the complaint in question available to the manufacturer at this time no failure confirmation can be provided.In addition from time to time feedback was received from the field that the guide wire is perceived as soft.For this reason based on these customer feedbacks a design change request was initiated concerning a change of the guide wire.This change is seen as a market driven product improvement and will be processed by the research and development department and is a not complaint related improvement.A supplement medwatch will be submitted if additional information becomes available.

Event Description

It was reported that during patient treatment it was difficult to use the avalon guidewire due to being not as stiff as other comparable guidewires.The patient died due to other issues and the death was not related to the use of the guidewire.Additional information : 08 september 2015: the patient did not die.It was only notified by the surgeon that the patient nearly died.(b)(4).

• Brand Name: AVALON ELITE VASCULAR ACCESS KIT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5110305
• MDR Text Key: 27147659
• Report Number: 8010762-2015-01068
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/03/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• 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