INDIGO SYSTEM SEPARATOR 6 SEP6

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 2020-03-27 for INDIGO SYSTEM SEPARATOR 6 SEP6 manufactured by Penumbra, Inc..

Event Text Entries

[188352408] 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.
Patient Sequence No: 1, Text Type: N, H10


[188352409] The patient was undergoing a thrombectomy procedure in the anterior tibial artery (at) using an indigo system separator 6 (sep6) and an indigo system aspiration catheter 6 (cat6). It should be noted that the patient's anatomy was calcified. During the procedure, after completing a few passes, the physician encountered resistance while advancing and retracting the sep6 within the cat6. Subsequently, the physician realized that the sep6 was stretched at the distal end and kinked in a few locations. Therefore, the sep6 was removed. The procedure was completed using another sep6 and the same cat6. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00465
MDR Report Key9892410
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-06
Date of Event2020-03-05
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-27
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 6
Generic NameDXE
Product CodeDXE
Date Received2020-03-27
Model NumberSEP6
Catalog NumberSEP6
Lot NumberF89289
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

Product Code---
Date Received2020-03-27
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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