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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
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BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA DILATATION CATHETER Back to Search Results
Model Number ATG120164
Medical Device Problem Codes Unraveled Material (1664); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was provided, therefore a lot history review was performed.The sample was returned for evaluation and the investigation is confirmed for unraveled fibers, device contamination, and packaging problem.The definitive root cause could not be determined based upon available information.The device was labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg120164 pta dilatation catheter allegedly experienced packaging problem, unraveled material, and foreign material.This information was received from one source.This malfunction did not involve a patient.The patient's age, weight and gender were not provided.
 
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Brand Name
ATLAS GOLD PTA DILATATION CATHETER
Common Device Name
PTA DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10736525
Report Number2020394-2020-06078
Device Sequence Number2113436
Product Code DQY
UDI-Device Identifier00801741060823
UDI-Public(01)00801741060823
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) 10/26/2020
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 NumberATG120164
Device Catalogue NumberATG120164
Device Lot Number93UC0205
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/26/2020
Patient Sequence Number1
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