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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY
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PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY Back to Search Results
Catalog Number 5MAXACE068
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 12/19/2016
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 disposed of the device.
 
Event or Problem Description
During preparation for a thrombectomy procedure, the physician noticed a penumbra system ace 68 reperfusion catheter (ace 68) was kinked upon removal from the packaging.The kinked ace 68 was noticed prior to use and therefore, it was not used in the procedure.The procedure was completed using a new ace 68.
 
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Brand Name
PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
Common Device Name
NRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key6258505
Report Number3005168196-2017-00081
Device Sequence Number10987845
Product Code NRY
UDI-Device Identifier00814548017525
UDI-Public00814548017525
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K161640
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) 12/21/2016
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 Date06/15/2019
Device Catalogue Number5MAXACE068
Device Lot NumberF70494
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2016
Initial Report FDA Received Date01/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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