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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM PUMP MAX CANISTER; DXE

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PENUMBRA, INC. INDIGO SYSTEM PUMP MAX CANISTER; DXE Back to Search Results
Catalog Number IAPS2
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2017
Event Type  malfunction  
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.This report is associated with mfr report number: 3005168196-2017-02192.The hospital disposed of the device.
 
Event Description
The patient was undergoing a thrombectomy procedure for an in-stent restenosis in the superficial femoral artery (sfa) using an indigo system separator 6 (sep6) and an indigo pump max canister (canister).During the procedure, while using the sep6 with an indigo system aspiration catheter 6 (cat6), the physician noticed that the indigo system was not aspirating properly.Upon checking the system, the hospital staff noticed that the canister had a crack in the side.Therefore, the canister was replaced with a new one and aspiration worked without issues.Later in the procedure, the scrub technologist inadvertently knocked the sep6 onto the floor.Therefore, the procedure was completed using a new sep6.There was no report of an adverse effect to the patient.
 
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Brand Name
INDIGO SYSTEM PUMP MAX CANISTER
Type of Device
DXE
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key7106905
MDR Text Key94822825
Report Number3005168196-2017-02193
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00814548013343
UDI-Public00814548013343
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2017
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
Device Operator Physician
Device Catalogue NumberIAPS2
Device Lot NumberF79834
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/14/2017
Initial Date FDA Received12/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age62 YR
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