LANTERN DELIVERY MICROCATHETER PXSLIMSTR-B PXSLIMSTR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for LANTERN DELIVERY MICROCATHETER PXSLIMSTR-B PXSLIMSTR manufactured by Penumbra, Inc..

Event Text Entries

[185228552] This device is available for return. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report number: 1. 3005168196-2020-00445.
Patient Sequence No: 1, Text Type: N, H10


[185228553] The patient was undergoing a coil embolization procedure to treat a carotid cavernous fistula (ccf) in the internal carotid artery (ica) using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim). During the procedure, the physician successfully placed a pc400 into the target vessel using the px slim. Upon removal of the pusher assembly, it was noticed that the pusher assembly broke into two pieces, leaving a broken piece stuck within the px slim. Therefore, the px slim containing the broken piece of the pusher assembly was removed. The procedure was completed using additional pc400s and a new px slim. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00446
MDR Report Key9886559
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-04
Date of Event2020-03-03
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-26
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 NameLANTERN DELIVERY MICROCATHETER
Generic NameDQY
Product CodeDQY
Date Received2020-03-26
Model NumberPXSLIMSTR-B
Catalog NumberPXSLIMSTR
Lot NumberF90403
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 Received2020-03-26
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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