• 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 DR13572
Device Problems Break (1069); Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the device was provided, a manufacturing review was performed.The device was returned to bd and is pending evaluation.The company is still investigating the issue at this time.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that the model dr13572 pta dilatation catheter allegedly failed to inflate and deflate.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient's age, sex and weight were not reported.
 
Manufacturer Narrative
H10: the lot number for the device was provided, and a lot history review was performed.The device was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for inflation problem and break; however, the investigation is inconclusive for deflation problem.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that the model dr13572 pta dilatation catheter allegedly failed to inflate and deflate.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient's age, sex and weight were not reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DORADO PTA DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10286691
MDR Text Key199245321
Report Number2020394-2020-04530
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741058936
UDI-Public(01)00801741058936
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/13/2020
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
Device Operator No Information
Device Model NumberDR13572
Device Catalogue NumberDR13572
Device Lot Number93XD0110
Initial Date Manufacturer Received 06/30/2020
Initial Date FDA Received07/16/2020
Supplement Dates Manufacturer Received09/30/2020
Supplement Dates FDA Received10/13/2020
Patient Sequence Number1
-
-