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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number 0244512
Device Problem Material Rupture (1546)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The device was returned for evaluation.The investigation is identified for longitudinal rupture.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicates that model 0244512 pta balloon dilatation catheter allegedly experienced balloon rupture.The information was received from one source.This event did not involve a patient as there was no patient contact.
 
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Brand Name
TRUE DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10276601
MDR Text Key198911036
Report Number2020394-2020-04455
Device Sequence Number1
Product Code OZT
UDI-Device Identifier00801741091018
UDI-Public(01)00801741091018
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2020
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
Device Operator No Information
Device Model Number0244512
Device Catalogue Number0244512
Device Lot NumberGFDQ1634
Initial Date Manufacturer Received 06/30/2020
Initial Date FDA Received07/15/2020
Type of Device Usage N
Patient Sequence Number1
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