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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY
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PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY Back to Search Results
Catalog Number PND6F070956
Medical Device Problem Codes Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/23/2017
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 medical procedure, the technologist noticed that the distal tip of the neuron 6f 070 delivery catheter (neuron 070) was crimped upon removing it from the packaging.The damaged neuron 070 was found prior to use and therefore, was not used in procedure.The procedure was completed using a new neuron 070.
 
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Brand Name
NEURON 6F 070 DELIVERY CATHETER
Common Device Name
DQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key6877361
Report Number3005168196-2017-01559
Device Sequence Number482757
Product Code DQY
UDI-Device Identifier00814548010069
UDI-Public00814548010069
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K082290
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date (Section B) 08/25/2017
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 Radiologic Technologist
Device Catalogue NumberPND6F070956
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/25/2017
Initial Report FDA Received Date09/19/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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