PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER 5MAXACE068

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 2020-03-05 for PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER 5MAXACE068 manufactured by Penumbra, Inc..

Event Text Entries

[188512105] 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


[188512106] The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and a non-penumbra guide catheter. During the procedure, while advancing the ace68 approximately 5-10 centimeters through the guide catheter, the physician experience resistance; therefore, the ace68 was removed. The procedure was completed using a new ace68. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00311
MDR Report Key9795844
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-03-05
Date of Report2020-02-13
Date of Event2020-02-02
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-13
Date Added to Maude2020-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 SYSTEM ACE 68 REPERFUSION CATHETER
Generic NameNRY
Product CodeNRY
Date Received2020-03-05
Model Number5MAXACE068
Catalog Number5MAXACE068
Lot NumberF87712
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 Received2020-03-05
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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