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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 U357584
Device Problems Leak/Splash (1354); Material Rupture (1546); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
For the reported malfunction, a lot number was provided, and a lot history review was performed. The sample was not returned for evaluation. Therefore, the investigation of the reported material rupture is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use.
 
Event Description
This report summarizes one malfunction. A review of the malfunction indicated that model u357584 pta balloon dilatation catheter allegedly experienced material rupture. This report was received from one source. This event did not involve a patient as there was no patient contact.
 
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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 Key9597966
MDR Text Key178330356
Report Number2020394-2020-00542
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 04/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU357584
Device Catalogue NumberU357584
Device Lot NumberCMDU0047
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 Received03/26/2020
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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