PENUMBRA SMART COIL 400SMTXSFT2H04

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-31 for PENUMBRA SMART COIL 400SMTXSFT2H04 manufactured by Penumbra, Inc..

Event Text Entries

[188359042] This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10


[188359043] The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter. It was reported that the patient? S anatomy was tortuous. During the procedure, while advancing a smart coil through the hub of the microcatheter, the physician encountered resistance; therefore, the smart coil and the microcatheter were removed. The procedure was completed using five non-penumbra coils and a non-penumbra microcatheter. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00431
MDR Report Key9907671
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-03-31
Date of Report2020-03-08
Date of Event2020-03-04
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-08
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. VERONICA FARRIS
Manufacturer StreetONE PENUMBRA PLACE
Manufacturer CityALAMEDA CA 94502
Manufacturer CountryUS
Manufacturer Postal94502
Manufacturer Phone5107483200
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NamePENUMBRA SMART COIL
Generic NameHCG, KRD
Product CodeHCG
Date Received2020-03-31
Model Number400SMTXSFT2H04
Catalog Number400SMTXSFT2H04
Lot NumberF86444
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

Product Code---
Date Received2020-03-31
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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