TRUE DILATATION CATHETER UNKNOWN TRUE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-08 for TRUE DILATATION CATHETER UNKNOWN TRUE manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[126652735] As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Patient Sequence No: 1, Text Type: N, H10


[126652736] It was reported that during a bioprosthetic valve fracturing procedure, the balloon allegedly ruptured longitudinally at 20atm. The balloon was removed in its entirety through the sheath without difficulty. The procedure was completed with another balloon. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2018-01997
MDR Report Key8053121
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-11-08
Date of Report2018-11-08
Date of Event2018-10-12
Date Mfgr Received2018-10-12
Date Added to Maude2018-11-08
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 ContactJUDITH LUDWIG
Manufacturer Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1C.R. BARD, INC. (GFO)
Manufacturer Street289 BAY ROAD
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal Code12804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUE DILATATION CATHETER
Generic NameBALLOON VALVULOPLASTY CATHETER
Product CodeOZT
Date Received2018-11-08
Catalog NumberUNKNOWN TRUE
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-08

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