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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 06/08/2020
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 right m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), and non-penumbra microcatheter. During the procedure, the physician completed one pass in the target vessel using the jet7 and neuron max. While advancing the jet7 through the neuron max during the second pass, the physician injected contrast media, which revealed the distal tip of the jet7 was fractured. Therefore, the jet7 was removed. After removal of the jet7, it was noticed that the patient had a carotid cavernous fistula. The physician then placed a penumbra smart coil (smart coil) and non-penumbra stent to treat the carotid cavernous fistula. The carotid cavernous fistula was reported to be related to the jet7.

 
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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 Key10222650
MDR Text Key197280101
Report Number3005168196-2020-00873
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 01/01/2005,06/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2020
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 NumberF94269
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2020
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
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/02/2020 Patient Sequence Number: 1
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