PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7KIT-B 5MAXJET7KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-03 for PENUMBRA SYSTEM JET7 REPERFUSION CATHETER 5MAXJET7KIT-B 5MAXJET7KIT manufactured by Penumbra, Inc..

Event Text Entries

[188495599] The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10


[188495600] The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), penumbra system 3max reperfusion catheter (3maxc), non-penumbra balloon guide catheter, non-penumbra stent retriever, non-penumbra microcatheter and, non-penumbra revascularization device. During the procedure, the physician made a couple of passes using the balloon guide catheter, stent retriever and, microcatheter. Next, the physician removed the microcatheter and stent retriever and inserted a 3maxc, guidewire and jet7. After several attempts with aspiration using the jet7 and 3maxc, a revascularization device was placed using the solumbra technique; however, it was noticed that there was no flow through the jet7 and into the canister. Therefore, the physician injected contrast into the jet7 and noticed that the distal tip of the jet7 was inflated and, therefore, it was removed. It was reported that the clot was unable to be removed using other devices and the physician decided to end the procedure resulting in thrombolysis in cerebral infarction (tici) 1. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00281
MDR Report Key9782590
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-03
Date of Report2020-02-10
Date of Event2020-02-09
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-17
Date Added to Maude2020-03-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. VERONICA FARRIS
Manufacturer StreetONE PENUMBRA PLACE
Manufacturer CityALAMEDA CA 94502
Manufacturer CountryUS
Manufacturer Postal94502
Manufacturer Phone5107483200
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NamePENUMBRA SYSTEM JET7 REPERFUSION CATHETER
Generic NameNRY
Product CodeNRY
Date Received2020-03-03
Returned To Mfg2020-02-13
Model Number5MAXJET7KIT-B
Catalog Number5MAXJET7KIT
Lot NumberF93961
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

Product Code---
Date Received2020-03-03
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-03

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