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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CATRX ASPIRATION CATHETER; QEX, QEW

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PENUMBRA, INC. INDIGO SYSTEM CATRX ASPIRATION CATHETER; QEX, QEW Back to Search Results
Catalog Number CATRXKIT
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/11/2024
Event Type  Injury  
Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number:(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
 
Event Description
The patient was undergoing a thrombectomy procedure using an indigo system catrx aspiration catheter (catrx).During the procedure, the catrx partially fractured inside the patient.It was reported that the physician was able to retrieve and remove the damaged catrx percutaneously and a flat plate x-ray was obtained.No additional information regarding the completion of the procedure was provided.
 
Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, 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.
 
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Brand Name
INDIGO SYSTEM CATRX ASPIRATION CATHETER
Type of Device
QEX, QEW
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key18909741
MDR Text Key337730132
Report Number3005168196-2024-00089
Device Sequence Number1
Product Code QEX
UDI-Device Identifier00814548017556
UDI-Public814548017556
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/01/2005,05/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCATRXKIT
Device Lot NumberF00008149
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 02/22/2024
Initial Date FDA Received03/14/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2023
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 Outcome(s) Required Intervention;
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