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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE
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PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE Back to Search Results
Catalog Number CAT3
Medical Device Problem Codes Hole In Material (1293); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/30/2018
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 physician found that the indigo system cat3 aspiration catheter (cat3) was torn at the hub upon removal from the packaging.The damage to the cat3 was found prior to use.Therefore, the cat3 was not used in the procedure.The procedure was completed using a new cat3.
 
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Brand Name
INDIGO SYSTEM CAT3 ASPIRATION CATHETER
Common Device Name
DXE
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7651125
Report Number3005168196-2018-01266
Device Sequence Number134720
Product Code DXE
UDI-Device Identifier00814548016085
UDI-Public00814548016085
Combination Product (Y/N)N
Initial Reporter StateSD
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) 06/01/2018
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 Date08/14/2020
Device Catalogue NumberCAT3
Device Lot NumberF78700
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/01/2018
Initial Report FDA Received Date06/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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