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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number AT75144
Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2018
Event Type  malfunction  
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer. The lot number for the device was not provided; therefore, a review of the device history records could not be performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.
 
Event Description
It was reported that during an angioplasty procedure in the cephalic arch, the pta balloon allegedly ruptured. There was no retraction issue through the sheath, no reported detached balloon fragments, and no vessel damage post balloon rupture. Another device was used to complete the procedure. There was no reported patient injury.
 
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Brand NameATLAS 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)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8012019
MDR Text Key125283042
Report Number2020394-2018-01944
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120971
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 01/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAT75144
Device Catalogue NumberAT75144
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
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

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