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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; VALVULOPLASTY BALLOON CATHETER
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BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; VALVULOPLASTY BALLOON CATHETER Back to Search Results
Model Number 0224512
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was not provided; therefore a lot history review was not performed.The device was not returned for evaluation; therefore the investigation is inconclusive as no objective evidence was provided for review.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 reported information indicates that model 0224512 valvuloplasty balloon catheter allegedly experienced a leak.The information was received from one source.The malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.
 
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Brand Name
TRUE DILATATION CATHETER
Common Device Name
VALVULOPLASTY BALLOON CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9965733
Report Number2020394-2020-02821
Device Sequence Number3835881
Product Code OZT
UDI-Device Identifier00801741091001
UDI-Public(01)00801741091001
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) 04/15/2020
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 Number0224512
Device Catalogue Number0224512
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/15/2020
Patient Sequence Number1
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