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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); Failure to Advance (2524)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Material separation and failure to advance were confirmed for the device.A root cause has not been determined.The device was labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cruos106.Recanalization catheter allegedly experienced material separation and failure to advance.This report was received from a single source.This event did involve patient with no reported patient injury.The patient's age, weight and gender were not provided.
 
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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 Key9195000
Report Number2020394-2019-03975
Device Sequence Number3935131
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) 10/15/2019
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 NumberGFDN4169
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/15/2019
Patient Sequence Number1
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