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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED72 REPERFUSION CATHETER NRY

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PENUMBRA, INC. PENUMBRA SYSTEM RED72 REPERFUSION CATHETER NRY Back to Search Results
Catalog Number RED72KIT
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2022
Event Type  malfunction  
Event Description
The patient was undergoing a thrombectomy procedure in the m2 inferior segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra microcatheter, and a guidewire. During the procedure, while advancing the red72 to the target vessel using the microcatheter for the first pass, the physician broke the red72 at the proximal end. Therefore, the red72 was removed. The procedure was completed using a new red72 and the same microcatheter. There was no report of an adverse effect to the patient.
 
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.
 
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Brand NamePENUMBRA SYSTEM RED72 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 Key15157583
MDR Text Key297452913
Report Number3005168196-2022-00366
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00815948023932
UDI-Public815948023932
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,08/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRED72KIT
Device Lot NumberH12723
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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