BARD? X-FORCE? BALLOON DILATION CATHETER 998404

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for BARD? X-FORCE? BALLOON DILATION CATHETER 998404 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[141925523] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[141925524] It was reported that the pressure did not rise after the catheter was inserted. Following removal, a crack was found on the shaft. The procedure was completed with another device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2019-01872
MDR Report Key8503256
Date Received2019-04-11
Date of Report2019-06-06
Date of Event2019-03-19
Date Mfgr Received2019-06-03
Device Manufacturer Date2018-09-05
Date Added to Maude2019-04-11
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 ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBARD? X-FORCE? BALLOON DILATION CATHETER
Generic NameX-FORCE
Product CodeEZN
Date Received2019-04-11
Returned To Mfg2019-04-02
Model Number998404
Catalog Number998404
Lot NumberBMCUFM34
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-11

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