INDIGO SYSTEM SEPARATOR 8 SEP8-A SEP8

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-01 for INDIGO SYSTEM SEPARATOR 8 SEP8-A SEP8 manufactured by Penumbra, Inc..

Event Text Entries

[185227561] This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
Patient Sequence No: 1, Text Type: N, H10


[185227562] The patient was undergoing a thrombectomy procedure in the femoral popliteal artery using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), a non-penumbra 9f sheath introducer, and guidewire. During the procedure, the physician advanced the cat8 over the guidewire through the 9f sheath to the target site. The guidewire was then removed and the sep8 was advanced through the cat8. Next, aspiration was initiated. While advancing the sep8 in and out of the cat8, the physician noticed under fluoroscopy that the wire distal to the bulb of the sep8 was broken. Therefore, the broken sep8 was aspirated out using the cat8. No additional information regarding the completion of the procedure was provided. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00123
MDR Report Key9656399
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-02-01
Date of Report2020-01-10
Date of Event2020-01-08
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-01-10
Date Added to Maude2020-02-01
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 8
Generic NameQEW
Product CodeQEW
Date Received2020-02-01
Model NumberSEP8-A
Catalog NumberSEP8
Lot NumberF91780
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

Product Code---
Date Received2020-02-01
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-01

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