CROSSER CTO RECANALIZATION CATHETERS CRE14S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for CROSSER CTO RECANALIZATION CATHETERS CRE14S manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[178248006] The catalog number identified has not been cleared in the us, but is similar to the crosser cto recanalization catheter products that are cleared in the us. The product code for the crosser cto recanalization catheter product is identified. For the reported malfunction, a lot number was provided, and a lot history review was performed. The sample was returned to the manufacturer for evaluation. After further evaluation, ,material separation was identified on the device. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10


[178248007] This report summarizes one (1) malfunction. A review of the reported malfunction indicated that model cre14s cto recanalization catheters experienced material separation and failure to advance. This report was received from one source. This malfunction involved a patient with no patient consequences. Age, weight, and gender was not provided for the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2020-00255
MDR Report Key9588851
Date Received2020-01-14
Date of Report2020-01-14
Date Mfgr Received2019-12-31
Date Added to Maude2020-01-14
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 NameCROSSER CTO RECANALIZATION CATHETERS
Generic NameRECANALIZATION CATHETER
Product CodePDU
Date Received2020-01-14
Catalog NumberCRE14S
Lot NumberGFCV0269
Device Availability*
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 2020-01-14

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