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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; DXE
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PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; DXE Back to Search Results
Catalog Number SEP8
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/01/2018
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 device is not available for return.
 
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system separator 8 (sep8).During the procedure, the sep8 broke and embolized.The physician did not attempt to retrieve the broken sep8 due to the patient's existing conditions.It was reported that the patient passed away due to a massive pulmonary embolism, and the death was unrelated to the indigo system.
 
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Brand Name
INDIGO SYSTEM SEPARATOR 8
Common Device Name
DXE
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7621572
Report Number3005168196-2018-01215
Device Sequence Number1382949
Product Code DXE
UDI-Device Identifier00814548016153
UDI-Public00814548016153
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K161523
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) 05/22/2018
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 Catalogue NumberSEP8
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/22/2018
Initial Report FDA Received Date06/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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