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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U35130530
Device Problem Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 01/30/2019
Event Type  Injury  
Manufacturer Narrative
The lot number for the device was not provided; therefore, a review of the device history records could not be performed. The return of the device is pending. The investigation of the reported event is currently underway.
 
Event Description
It was reported that at the completion of an angioplasty procedure in the superficial femoral artery, resistance was allegedly felt when removing the guidewire. The pta balloon and guidewire were removed as a single unit, which resulted in a tear at the access site the left common femoral artery. It was further reported that there was bleeding at the access site, for about an hour. The bleeding was stopped with astriction and no further treatment was needed. There were no further complications to the patient.
 
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Brand NameULTRAVERSE 035 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
EI
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8351115
MDR Text Key136519993
Report Number2020394-2019-00137
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU35130530
Device Catalogue NumberU35130530
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
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: 02/19/2019 Patient Sequence Number: 1
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