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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 U4150330
Device Problems Burst Container or Vessel (1074); Material Rupture (1546)
Patient Problems Perforation (2001); Vascular Dissection (3160)
Event Date 06/09/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the sample is pending. The investigation of the reported event is currently underway. Expiry date (12/2022).
 
Event Description
It was reported that during an angioplasty procedure through tibial artery, the pta balloon allegedly had a pinhole ruptured at 4 atm in the posterior tibial (pt) artery. It was further reported that the treatment plan changed to at/pedal loop. The procedure was completed using another device. The patient status is unknown.
 
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Brand NameULTRAVERSE 014 PTA DILATATION 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 Key10211107
MDR Text Key196907739
Report Number2020394-2020-04137
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU4150330
Device Catalogue NumberU4150330
Device Lot NumberCMEN0166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/30/2020 Patient Sequence Number: 1
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