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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETER Back to Search Results
Model Number CRUS6106
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will 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 device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model crus6106 recanalization catheter allegedly the tip detached after five minutes of activation. the tip remains in the patient.There was no reported patient injury.This information was received from one source.Patient was male, age and weight were not provided.
 
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Brand Name
CROSSER CTO RECANALIZATION CATHETER
Common Device Name
RECANALIZATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8807569
Report Number2020394-2019-01608
Device Sequence Number2693827
Product Code PDU
UDI-Device Identifier10801741125642
UDI-Public(01)10801741125642
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberCRUS6106
Device Catalogue NumberCRUS6106
Device Lot NumberGFCY3720
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2019
Initial Report FDA Received Date07/19/2019
Patient Sequence Number1
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