TRUE DILATATION CATHETER 0264513

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for TRUE DILATATION CATHETER 0264513 manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[174535064] The lot number was not provided so a lot history review could not be performed. The device was returned to bd for evaluation. The investigation identified for material rupture. Based on the information provided, the definitive root cause in unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10


[174535065] This report summarizes one malfunction. A review of the reported information indicated that model 0264513 pta balloon dilatation catheter allegedly experienced material rupture. This information was received from one source. This malfunction involved a patient with no reported patient injury. The patient's age, weight, and gender were not provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2020-00186
MDR Report Key9572519
Date Received2020-01-09
Date of Report2020-03-30
Date Mfgr Received2020-03-24
Date Added to Maude2020-01-09
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 Street1415 W. 3RD STREET
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 NamePTA BALLOON DILATATION CATHETER
Product CodeOZT
Date Received2020-01-09
Model Number0264513
Catalog Number0264513
Lot NumberUNKNOWN
Device Availability*
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-09

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