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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number ATG120184
Medical Device Problem Codes Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for the reported leak and balloon rupture.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.
 
Event or Problem Description
A review of the reported information indicated that model atg120184 pta balloon dilatation catheter allegedly experienced leak and material rupture.This information was received from one source.One patient was involved with no reported patient injury.The patient age, weight, and gender were not provided.
 
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Brand Name
ATLAS GOLD 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 Key11686030
Report Number2020394-2021-80320
Device Sequence Number11516835
Product Code DQY
UDI-Device Identifier00801741060885
UDI-Public(01)00801741060885
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/19/2021
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 NumberATG120184
Device Catalogue NumberATG120184
Device Lot Number93ZD0104
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/31/2021
Initial Report FDA Received Date04/19/2021
Patient Sequence Number1
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