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. DORADO PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
  • 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. DORADO PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number DR80810
Medical Device Problem Codes Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation identified a break and a retraction problem.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model dr80810 pta balloon dilatation catheter allegedly experienced a break and retraction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient was (b)(6) lbs.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DORADO PTA DILATATION CATHETER
Common Device Name
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8823029
Report Number2020394-2019-01807
Device Sequence Number16853753
Product Code DQY
UDI-Device Identifier00801741059360
UDI-Public(01)00801741059360
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) 07/24/2019
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 NumberDR80810
Device Catalogue NumberDR80810
Device Lot Number93TC0028
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2019
Initial Report FDA Received Date07/24/2019
Patient Sequence Number1
-
-