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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS TRACHEOBRONCHAIL STENT GRAFT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS TRACHEOBRONCHAIL STENT GRAFT Back to Search Results
Catalog Number FTM08040
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/30/2013
Event Type  malfunction  
Event Description
It was reported that during a stent graft placement procedure in the iliac artery, upon completion of the successful stent graft deployment the distal tip of the deployment system detached upon removal.A snare device was used to successfully retrieve the detached tip.No pt injury was reported.
 
Manufacturer Narrative
The lot number of the subject device has not been provided; therefore, a device history record review could not be performed.The investigation is currently underway.
 
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Brand Name
FLUENCY PLUS TRACHEOBRONCHAIL STENT GRAFT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe
GM 
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 7622 7
GM   76227
Manufacturer Contact
daniela mueller
wachhausstrasse 6
karlsruhe 76227
GM   76227
2194450
MDR Report Key3770014
MDR Text Key4380163
Report Number9681442-2014-00018
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/31/2013
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 Catalogue NumberFTM08040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/31/2013
Initial Date FDA Received01/28/2014
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
Patient Sequence Number1
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