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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET MEDICAL SYSTEMS USA VASCULAR ACCESS KIT; DUAL LUMEN CANNULA
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MAQUET MEDICAL SYSTEMS USA VASCULAR ACCESS KIT; DUAL LUMEN CANNULA Back to Search Results
Model Number 12210
Device Problem Difficult to Remove (1528)
Patient Problems Death (1802); Heart Failure (2206)
Event Date 12/02/2013
Event Type  No Answer Provided  
Event Description
It was reported there was a problem with a dual lumen cannula.The guidewire became knotted at the end of the wire after it was inside the patient and the surgeon could not remove the wire.The surgeon was able to remove the wire with the introducer, un-knot the wire and then place it back in to remove the wire.The customer felt the wire was too flimsy.It was later reported that the patient expired due to heart failure because a transplant recipient could not be found in time.(b)(4).Ref# mfr 8010762-2014-00030.
 
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Brand Name
VASCULAR ACCESS KIT
Type of Device
DUAL LUMEN CANNULA
Manufacturer (Section D)
MAQUET MEDICAL SYSTEMS USA
45 barbour pond drive
wayne NJ 07470 000
Manufacturer (Section G)
MAQUET MEDICAL SYSTEMS USA
45 barbour pond drive
wayne NJ 07470 000
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470-0000
MDR Report Key3598939
MDR Text Key4169585
Report Number3008355164-2014-00011
Device Sequence Number1
Product Code DWF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/24/2014,12/27/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2016
Device Model Number12210
Device Catalogue Number701063540
Device Lot NumberAM014769
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/27/2013
Device Age9 MO
Event Location Hospital
Date Report to Manufacturer12/30/2013
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/24/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Weight91
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