FORMULA 418 RENAL BALLOON-EXPANDABLE STENT G56611 FOR418-18-80-6-12

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 2020-02-20 for FORMULA 418 RENAL BALLOON-EXPANDABLE STENT G56611 FOR418-18-80-6-12 manufactured by Cook Inc.

Event Text Entries

[184138720] Common name & product code: nin, stent, renal. Occupation: unknown. Pma/510(k) number: p100028. Device evaluated by mfg: device evaluation has begun; however, a conclusion is not yet available. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[184138721] As reported, during placement of a stent within the renal artery, two formula 418 renal balloon-expandable stents came off the delivery systems. The procedure was ultimately aborted due to hemodynamic changes in the patient. There has been no report that this event caused or contributed to the hemodynamic changes. Per the initial reporter, a section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00406
MDR Report Key9732368
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-20
Date of Report2020-03-05
Date of Event2020-02-05
Date Mfgr Received2020-02-25
Device Manufacturer Date2019-11-15
Date Added to Maude2020-02-20
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 ContactMRS. JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFORMULA 418 RENAL BALLOON-EXPANDABLE STENT
Product CodeNIN
Date Received2020-02-20
Returned To Mfg2020-02-12
Model NumberG56611
Catalog NumberFOR418-18-80-6-12
Lot Number10153876
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-20

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