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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 CRUS6A
Medical Device Problem Codes Fracture (1260); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was provided, therefore a lot history review was performed.The sample was returned for evaluation and fracture and torn material was confirmed.The investigation is unconfirmed for material twisted/bent.The definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model crus6a recanalization catheter experienced a fracture, twisted material, and material split.The information was received from one source.The malfunction involved a patient with no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) pounds.
 
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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 Key9591279
Report Number2020394-2020-00275
Device Sequence Number534831
Product Code PDU
UDI-Device Identifier10801741125659
UDI-Public(01)10801741125659
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) 01/15/2020
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 NumberCRUS6A
Device Catalogue NumberCRUS6A
Device Lot NumberGFDR1661
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/31/2019
Initial Report FDA Received Date01/15/2020
Patient Sequence Number1
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