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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 Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem Fistula (1862)
Event Date 03/16/2020
Event Type  Injury  
Manufacturer Narrative

Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, arteriovenous fistula, vessel spasm, thrombosis, dissection or perforation, including death. Therefore, it was determined that the reported adverse event was an anticipated complication. 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.

 
Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter, and a non-penumbra revascularization device. During the procedure, upon completion of the third pass using the jet7 and revascularization device, resistance was encountered while retracting the non-penumbra stent retriever. After removing the stent retriever, the physician performed an angiogram that revealed a vessel injury. The jet7 was then removed and the physician realized it was split open at the distal end. It was also reported that upon removal of the jet7, the patient's head turned as if reacting to pain. The procedure was continued using another jet7, the same microcatheter, and a non-penumbra stent retriever. Although the patient had remaining clot in the mca after the fourth pass, the physician decided it was too risky to continue and ended the procedure. The following day, another procedure was performed to embolize the fistula using penumbra coil 400s (pc400s). The medical status of the patient is unknown.

 
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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 Key9960106
MDR Text Key187696637
Report Number3005168196-2020-00548
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 01/01/2005,03/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2020
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 NumberF94084
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2020
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 Received05/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/06/2019
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: 04/14/2020 Patient Sequence Number: 1
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