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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE
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PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE Back to Search Results
Catalog Number CAT8STR85
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 05/16/2018
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 discarded the device.
 
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital technician accidentally kinked the indigo system aspiration catheter 8 (cat8) upon removal from the packaging.The damage to the cat8 was found prior to use.Therefore, the cat8 was not used in the procedure.The procedure was completed using a new cat8.
 
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Brand Name
INDIGO SYSTEM ASPIRATION CATHETER 8
Common Device Name
DXE
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7601444
Report Number3005168196-2018-01184
Device Sequence Number1624100
Product Code DXE
UDI-Device Identifier00814548016269
UDI-Public00814548016269
Combination Product (Y/N)N
Initial Reporter StateMO
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 Health Care Professional
Type of Report Initial
Report Date (Section B) 05/16/2018
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 Radiologic Technologist
Device Expiration Date07/04/2020
Device Catalogue NumberCAT8STR85
Device Lot NumberF78013
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/16/2018
Initial Report FDA Received Date06/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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