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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER D; DXE
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PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER D; DXE Back to Search Results
Catalog Number CATD
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 04/11/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.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.
 
Event or Problem Description
During preparation for a thrombectomy procedure, the physician found that the indigo system aspiration catheter d (catd) was kinked upon removal from the packaging.The damage to the catd was found prior to use and therefore, the catd was not used in the procedure.The procedure was completed using a new catd.
 
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Brand Name
INDIGO SYSTEM ASPIRATION CATHETER D
Common Device Name
DXE
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7498789
Report Number3005168196-2018-00969
Device Sequence Number18871880
Product Code DXE
UDI-Device Identifier00814548017624
UDI-Public00814548017624
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K160533
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) 04/11/2018
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 Date02/22/2020
Device Catalogue NumberCATD
Device Lot NumberF74552
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/11/2018
Initial Report FDA Received Date05/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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