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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCENTRIC MEDICAL FLOWGATE2 8F X 85CM CATHETER, PERCUTANEOUS

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CONCENTRIC MEDICAL FLOWGATE2 8F X 85CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number 90485
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2016
Event Type  Malfunction  
Manufacturer Narrative

Device is not available.

 
Event Description

It was reported that the distal radio opaque marker of the balloon guide catheter were loose. No further information was provided.

 
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Brand NameFLOWGATE2 8F X 85CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
CONCENTRIC MEDICAL
301 east evelyn
mountain view CA 94041
Manufacturer (Section G)
CONCENTRIC MEDICAL
301 east evelyn
mountain view CA 94041
Manufacturer Contact
tara lopez
301 east evelyn
mountain view, CA 94041
6509382100
MDR Report Key6200032
MDR Text Key63199255
Report Number0002954917-2016-00173
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number90485
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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