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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 053 DELIVERY CATHETER; DQY
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PENUMBRA, INC. NEURON 6F 053 DELIVERY CATHETER; DQY Back to Search Results
Catalog Number PND6F1156M
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 07/28/2017
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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital discarded the device.
 
Event or Problem Description
During preparation for a thrombectomy procedure, the physician noticed that a neuron 6f 053 delivery catheter (neuron 053) was kinked near the hub upon opening the packaging and prior to removing the neuron 053.The damaged neuron 053 was found prior to use and therefore, was not used for the procedure.The procedure was completed using another neuron 053.
 
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Brand Name
NEURON 6F 053 DELIVERY CATHETER
Common Device Name
DQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key6812106
Report Number3005168196-2017-01424
Device Sequence Number13490158
Product Code DQY
UDI-Device Identifier00814548010151
UDI-Public00814548010151
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K070970
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/28/2017
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 Physician
Device Expiration Date08/16/2019
Device Catalogue NumberPND6F1156M
Device Lot NumberF71131
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/28/2017
Initial Report FDA Received Date08/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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