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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER. DQY

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PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER. DQY Back to Search Results
Catalog Number PXSLIMSTR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Muscle Spasm(s) (1966)
Event Date 12/19/2014
Event Type  Malfunction  
Event Description

The patient was undergoing a coil embolization procedure in the right gastric artery using ruby coils and a px slim delivery microcatheter. During the procedure, the patient experienced a vasospasm with an unsure relationship to the ruby coils and slim microcatheter. The devices were removed from the patient and the spasm resolved itself within minutes. The physician was content with the results and ended the procedure.

 
Manufacturer Narrative

Conclusion: vasospasm is a known and anticipated complication with these types of procedures and are noted in the device labeling. Therefore, it was determined that the reported event was an anticipated procedural complication. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This mdr is associated with mdr 3005168196-2015-00049. The hospital discarded the device.

 
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Brand NamePX SLIM DELIVERY MICROCATHETER.
Type of DeviceDQY
Manufacturer (Section D)
PENUMBRA, INC.
1351 harbor bay parkway
alameda CA 94502
Manufacturer (Section G)
PENUMBRA, INC.
1351 harbor bay parkway
alameda CA 94502
Manufacturer Contact
kathleen kidd
1351 harbor bay parkway
alameda, CA 94502
5107483200
MDR Report Key4429248
MDR Text Key5281668
Report Number3005168196-2015-00051
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/19/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/31/2017
Device Catalogue NumberPXSLIMSTR
Device LOT NumberF42233
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/19/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/25/2014
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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