Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS Back to Search Results
Model Number CRUO14SA
Medical Device Problem Codes Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was provided for the reported malfunction, therefore a lot history review was performed.The sample was returned for evaluation.The investigation is identified for material separation.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 cruo14sa recanalization catheter allegedly experienced material separation and device-device incompatibility.The information was received from a single source.This malfunction did not involve a patient as there was no patient contact.Age, weight, and gender of the patient was not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10268724
Report Number2020394-2020-04397
Device Sequence Number2310099
Product Code PDU
UDI-Device Identifier10801741125598
UDI-Public(01)10801741125598
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) 07/13/2020
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 NumberCRUO14SA
Device Catalogue NumberCRUO14SA
Device Lot NumberGFCT1829
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/13/2020
Patient Sequence Number1
-
-