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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U354054
Device Problems Inflation Problem (1310); Material Rupture (1546); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed. The device has been returned for evaluation; the evaluation identified material split, cut, or torn. 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 u354054 pta balloon dilatation catheter allegedly experienced an inflation issue and material rupture. This information was received from one source. The malfunction involved one patient with no patient consequences. The age, weight, and gender of the patient were not provided.
 
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Brand NameULTRAVERSE 035 PTA CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9591280
MDR Text Key179311404
Report Number2020394-2020-00277
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU354054
Device Catalogue NumberU354054
Device Lot NumberCMDQ0516
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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