INDIGO SYSTEM CAT RX ASPIRATION CATHETER CATRXKIT

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 2020-03-18 for INDIGO SYSTEM CAT RX ASPIRATION CATHETER CATRXKIT manufactured by Penumbra, Inc..

Event Text Entries

[188412672] 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


[188412673] The patient was undergoing a thrombectomy procedure in the circumflex artery using an indigo system catrx aspiration catheter (catrx) and non-penumbra sheath. During the procedure, it was reported that the physician attempted to use a non-penumbra aspiration device and then ballooned a segment burden with heavy thrombus. However, thrombus traveled downstream to the circumflex artery and occluded the circumflex. The physician advanced catrx down the circumflex and completed two passes. After the second pass, the catrx was removed and the physician took a picture and discovered that the circumflex was still occluded. While attempting to advance the same catrx to make another pass, the physician noticed that the catrx to be kinked approximately three to four inches from the distal tip. Therefore, the catrx was removed the procedure was completed using a new catrx and the same sheath. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00382
MDR Report Key9849835
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-18
Date of Report2020-02-24
Date of Event2020-02-23
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-18
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 CAT RX ASPIRATION CATHETER
Generic NameDXE
Product CodeDXE
Date Received2020-03-18
Model NumberCATRXKIT
Catalog NumberCATRXKIT
Lot NumberF94432
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 Received2020-03-18
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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