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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX HI-FLOW KIT; NRY
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PENUMBRA, INC. PENUMBRA SYSTEM 4MAX HI-FLOW KIT; NRY Back to Search Results
Catalog Number 4MAXCKIT
Medical Device Problem Codes Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/21/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital disposed of the device.
 
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed that the penumbra system 4max reperfusion catheter (4max) was kinked upon removal from the packaging.The kinked 4max was noticed prior to use and therefore, was not used in the procedure.The procedure was completed using a new 4max.
 
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Brand Name
PENUMBRA SYSTEM 4MAX HI-FLOW KIT
Common Device Name
NRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key6425794
Report Number3005168196-2017-00434
Device Sequence Number10897108
Product Code NRY
UDI-Device Identifier00814548016740
UDI-Public00814548016740
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K160449
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number4MAXCKIT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/21/2017
Initial Report FDA Received Date03/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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