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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY

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PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY Back to Search Results
Model Number 5MAXJET7KIT-B
Device Problem Break (1069)
Patient Problem Fistula (1862)
Event Date 07/04/2020
Event Type  Injury  
Manufacturer Narrative

The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), a penumbra system aspiration pump max 110 (pump max), a non-penumbra catheter, a non-penumbra microcatheter, a non-penumbra stent retriever device, and a wire. During the procedure, the physician advanced the jet7, microcatheter and stent retriever device through the neuron max and up to the thrombus. The physician then deployed the stent retriever device, removed the microcatheter and turned on the pump max for aspiration. Subsequently, the stent retriever with the clot was pulled back into the jet7 and removed. With the jet7 in the carotid terminus, the physician did a contrast injection and noticed a carotid-cavernous sinus fistula (ccf). Next, while advancing a wire through the jet7, the wire went out the side of the jet7, and the physician realized that the distal tip of the jet7 was broken and was in the carotid. Therefore, the physician snared out the tip of the jet7 and coiled the ccf. The procedure ended at this point. The ccf was reported to be related to the jet7. The patient is currently recovering from the severe stroke suffered prior to the procedure.

 
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Brand NamePENUMBRA SYSTEM JET7 REPERFUSION CATHETER
Type of DeviceNRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key10348254
MDR Text Key201233578
Report Number3005168196-2020-01064
Device Sequence Number1
Product Code NRY
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK190010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,07/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5MAXJET7KIT-B
Device Catalogue Number5MAXJET7KIT
Device LOT NumberF94645
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2020
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 Received08/06/2020
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/30/2020 Patient Sequence Number: 1
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