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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASIPRATION TUBING; DXE
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PENUMBRA, INC. INDIGO SYSTEM ASIPRATION TUBING; DXE Back to Search Results
Catalog Number IST3
Medical Device Problem Code Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/23/2018
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 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 indigo system aspiration tubing (aspiration tubing) was dropped on the floor upon removal from the packaging.The aspiration tubing was dropped prior to use and therefore, was not used in the procedure.The procedure was completed using a new aspiration tubing.
 
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Brand Name
INDIGO SYSTEM ASIPRATION TUBING
Common Device Name
DXE
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7346240
Report Number3005168196-2018-00576
Device Sequence Number69848
Product Code DXE
UDI-Device Identifier00814548016221
UDI-Public00814548016221
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 Physician
Type of Report Initial
Report Date (Section B) 02/23/2018
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 Health Professional
Device Expiration Date11/26/2020
Device Catalogue NumberIST3
Device Lot NumberF80695
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/23/2018
Initial Report FDA Received Date03/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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