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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PUMP MAX CANISTER JCX

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PENUMBRA, INC. PUMP MAX CANISTER JCX Back to Search Results
Model Number PAPS2
Device Problem Device Contamination with Body Fluid
Event Date 11/01/2019
Event Type  Malfunction  
Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

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.

 
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Brand NamePUMP MAX CANISTER
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key9407007
Report Number3005168196-2019-02230
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,11/07/2019
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPAPS2
Device Catalogue NumberPAPS2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received02/21/2020
Is this a Reprocessed and Reused Single-Use Device? No

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