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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS
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BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS Back to Search Results
Model Number CRUOS106
Medical Device Problem Codes Material Separation (1562); Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model cruos106 crosser cto recanalization catheter experienced material separation and twisting of material.Of this event, the device was used on the patient with no reported injury.The male patient weighed (b)(6) kgs.And did not have his age provided.The cruos106 crosser cto recanalization catheter was returned to the manufacturer along with two pictures.The investigation confirmed both product problems.Neither the dhr review nor the investigation were able to determine a root cause.The device was labeled for single use.
 
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Brand Name
CROSSER CTO RECANALIZATION CATHETERS
Common Device Name
RECANALIZATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8533485
Report Number2020394-2019-00503
Device Sequence Number16624313
Product Code PDU
UDI-Device Identifier10801741125611
UDI-Public(01)10801741125611
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) 04/19/2019
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 NumberCRUOS106
Device Catalogue NumberCRUOS106
Device Lot NumberGFCP3833
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2019
Initial Report FDA Received Date04/19/2019
Patient Sequence Number1
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