INDIGO SYSTEM SEPARATOR D SEPD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for INDIGO SYSTEM SEPARATOR D SEPD manufactured by Penumbra, Inc..

Event Text Entries

[187696190] The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10


[187696191] The patient was undergoing a thrombectomy procedure in the left subclavian vein using an indigo system separator d (sepd), indigo system catd aspiration catheter (catd), and wire (unknown). During the procedure, while advancing the sepd in and out of the catd, the physician noticed under fluoroscopy that the wire distal to the bulb of the sepd was broken. Therefore, the physician used a snare device to successfully remove the broken sepd wire. The procedure ended at this point. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00399
MDR Report Key9851432
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-19
Date of Report2020-02-26
Date of Event2020-02-26
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-27
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. VERONICA FARRIS
Manufacturer StreetONE PENUMBRA PLACE
Manufacturer CityALAMEDA CA 94502
Manufacturer CountryUS
Manufacturer Postal94502
Manufacturer Phone5107483200
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameINDIGO SYSTEM SEPARATOR D
Generic NameDXE
Product CodeDXE
Date Received2020-03-19
Returned To Mfg2020-03-03
Catalog NumberSEPD
Lot NumberF82883
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

Product Code---
Date Received2020-03-19
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-19

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