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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 U357586
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem Injury (2348)
Event Date 04/14/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a lot history review is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Medical device - expiry date: 05/2022.
 
Event Description
It was reported that during an angioplasty procedure in the brachial artery, the pta balloon allegedly ruptured. It was further reported that the balloon tore in half after the delivery system became stuck on the guidewire. Reportedly, medical intervention was required to remove the detached segment. The detached segment was successfully removed from the patient. Patient is reportedly stable.
 
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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 Key10047828
MDR Text Key190650491
Report Number2020394-2020-03389
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142261
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 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU357586
Device Catalogue NumberU357586
Device Lot NumberCMDT0608
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
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: 05/12/2020 Patient Sequence Number: 1
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