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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U4100222
Device Problems Break (1069); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified break and packaging issue.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model u4100222 pta balloon dilatation catheter allegedly experienced break and packaging issue.This information was received from one source.This event did not involve a patient as there was no patient contact.The patient's age, weight and gender were not provided.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model u4100222 pta balloon dilatation catheter allegedly experienced break and packaging issue.This information was received from one source.This event did not involve a patient as there was no patient contact.The patient's age, weight and gender were not provided.
 
Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.2907 - detachment of device was identified for the device.The device has been returned for evaluation; the evaluation confirmed a break and detachment of device; however the investigation is inconclusive for the reported packaging issue.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4, h6 device code + description (2907 - detachment).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.
 
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Brand Name
ULTRAVERSE 014 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 Key9598086
MDR Text Key178330431
Report Number2020394-2020-00547
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741053450
UDI-Public(01)00801741053450
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 04/06/2020
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 NumberU4100222
Device Catalogue NumberU4100222
Device Lot NumberCMDS0151
Initial Date Manufacturer Received 12/31/2019
Initial Date FDA Received01/16/2020
Supplement Dates Manufacturer Received03/30/2020
Supplement Dates FDA Received04/06/2020
Patient Sequence Number1
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