PUMP MAX CANISTER PAPS2

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 2019-12-03 for PUMP MAX CANISTER PAPS2 manufactured by Penumbra, Inc..

Event Text Entries

[169025549] 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


[169025550] The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra max canister (canister). During the procedure, the physician noticed that the tubing connected to the filter of the penumbra system aspiration pump max 110 (pump max) had blood in it; therefore, the canister was removed. The procedure was completed using another canister and the same pump max. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2019-02230
MDR Report Key9407007
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-12-03
Date of Report2019-11-07
Date of Event2019-11-01
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-21
Date Added to Maude2019-12-03
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 NamePUMP MAX CANISTER
Generic NameJCX
Product CodeJCX
Date Received2019-12-03
Returned To Mfg2019-11-18
Model NumberPAPS2
Catalog NumberPAPS2
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

Product Code---
Date Received2019-12-03
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-03

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