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 DR80102
Medical Device Problem Codes Leak/Splash (1354); Material Rupture (1546)
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 not returned for evaluation.The investigation is inconclusive for the reported balloon leak.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 malfunction indicated that model dr80102 pta balloon dilatation catheter allegedly leaked.This report was received from one source.One patient was involved with no reported patient injury.The male patient is (b)(6) years old.Weight of the patient was not provided.
 
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 Key10286673
Report Number2020394-2020-04533
Device Sequence Number485713
Product Code LIT
UDI-Device Identifier00801741059490
UDI-Public(01)00801741059490
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) 07/16/2020
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 NumberDR80102
Device Catalogue NumberDR80102
Device Lot Number93WD0064
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/16/2020
Patient Sequence Number1
-
-