PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER 3MAXC-B 3MAXC

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 2020-03-11 for PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER 3MAXC-B 3MAXC manufactured by Penumbra, Inc..

Event Text Entries

[184327949] 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. This report is associated with mfr report number: 3005168196-2020-00316.
Patient Sequence No: 1, Text Type: N, H10


[184327950] The patient was undergoing a thrombectomy procedure to treat a supraclinoid carotid occlusion using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system jetd reperfusion catheter (jetd), and a neuron max 6f 088 long sheath (neuron max). It was noted that the patient anatomy was tortuous. During the procedure, the physician advanced the neuron max into the patient, then used the 3maxc to bring up the jetd to the treatment site through the neuron max. While attempting to remove the 3maxc, the physician experienced resistance. The physician then pulled harder and noticed that the 3maxc was stuck in the jetd. The physician then pulled even harder and was able to remove the 3maxc. However, upon removal, it was noticed that the 3maxc was broken and only the proximal end of the 3maxc was removed. The physician then removed the jetd and noticed that the broken distal end of the 3maxc was inside the jetd. The procedure was completed using a microcatheter, a stent retriever and the same neuron max. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00315
MDR Report Key9818473
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-03-11
Date of Report2020-02-10
Date of Event2020-01-29
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-10
Date Added to Maude2020-03-11
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 NamePENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
Generic NameNRY
Product CodeNRY
Date Received2020-03-11
Model Number3MAXC-B
Catalog Number3MAXC
Lot NumberC17816
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 Received2020-03-11
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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