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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 Misconnection; Improper Flow or Infusion; Device Handling Problem
Event Date 08/06/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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: 3005168196-2016-01275.

 
Event Description

The patient was undergoing a thrombectomy procedure for a cerebral infarction in the right middle cerebral artery (mca) using a penumbra system aspiration pump max 110v (pump max) and the penumbra system max aspiration tubing (tubing). During the procedure, although the patient had slightly tortuous vessels, the physician was able to approach the right mca with a penumbra system ace reperfusion catheter (ace). The physician's assistant prepared for the procedure by connecting the clean side of the tubing to the hub of the ace and setting up the pump max and canister for aspiration. The pump max was then turned on and aspiration was initiated. However, after waiting about ninety seconds, the physician noticed a gradual back flow of blood into the pump max and then noticed that the assistant had inappropriately connected the backside end of the tubing by mistake. Therefore, the pump max was immediately turned off and the devices were reconnected appropriately. The physician then re-initiated aspiration and noticed that the aspiration pressure was normal. Additionally, there was no longer a back flow of blood into the pump max. Thereafter, the procedure was completed using the same penumbra devices without any further issues. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. The device had blood inside and is no longer available for return.

 
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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
kathleen kidd
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key5934603
Report Number3005168196-2016-01274
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/07/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX110
Device LOT NumberF12110-04
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/06/2014
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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