NEURON SELECT CATHETER 5F BMK6F95MBER120

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 2020-03-26 for NEURON SELECT CATHETER 5F BMK6F95MBER120 manufactured by Penumbra, Inc..

Event Text Entries

[185229292] The device has been returned and the investigation results are pending. A follow up mdr will be submitted upon completion of the device investigation. This report is associated with mfr report number: 3005168196-2020-00448.
Patient Sequence No: 1, Text Type: N, H10


[185229293] The patient was undergoing a thrombectomy procedure in the right radial artery using a benchmark 6f 071 delivery catheter (benchmark) and a neuron select catheter 5f (5f select) from a benchmark kit. During the procedure, the physician encountered resistance while advancing the 5f select into the benchmark. Upon removal of the 5f select, the physician found a wire from the benchmark attached. Subsequently, the physician realized the benchmark was unraveling. It was also reported that purple coating was coming off of the 5f select. Therefore, the benchmark and 5f select were no longer used in the procedure. The procedure was completed using a new benchmark and a new 5f select from a new benchmark kit. There was no report of an adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005168196-2020-00449
MDR Report Key9886627
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-03
Date of Event2020-02-29
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-26
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 NameNEURON SELECT CATHETER 5F
Generic NameDQY
Product CodeDQY
Date Received2020-03-26
Returned To Mfg2020-03-06
Model NumberBMK6F95MBER120
Catalog NumberBMK6F95MBER120
Lot NumberF93649
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerPENUMBRA, INC.
Manufacturer AddressONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502

Device Sequence Number: 101

Product Code---
Date Received2020-03-26
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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