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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX Back to Search Results
Catalog Number PMX110
Device Problems Failure to Pump; No Pressure
Event Date 12/08/2016
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 using a penumbra system aspiration pump max 110 v (pump max). Prior to the procedure, the patient had carotid stenosis on both sides of the internal carotid artery (ica), which was treated by placing a stent in the left ica. After the stenting procedure, thrombus was confirmed in the distal m1 segment of the ica. Thereafter, the physician attempted to aspirate the thrombus using the pump max and a penumbra system 5max ace reperfusion catheter (5max ace). The pump max was powered on with the green light illuminated and the cooling fan operating; however, no vacuum was produced. Therefore, the procedure was successfully completed using a syringe. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

Results: the penumbra system aspiration pump max 110v (pump max) was opened by a penumbra investigator and corrosion was observed on the outlet cylinder piston crown. Conclusions: evaluation of the returned pump max confirmed that even though power was supplied to the pump max, the vacuum pump would not turn on. The pump housing was removed, and the vacuum pump was opened by penumbra engineers. It was observed that the piston crown in the outlet cylinder was corroded. The observed corrosion likely caused the piston to seize inside the cylinder. The root cause of this corrosion could not be determined. The 5max ace mentioned in the complaint was not returned for evaluation. Penumbra pumps are visually and functionally inspected during incoming quality inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
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 Key6244345
Report Number3005168196-2017-00031
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/11/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF17186-11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/26/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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