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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER
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BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER Back to Search Results
Model Number DR8064
Device Problems Peeled / Delaminated; Material Rupture
Event Type  Malfunction  
Manufacturer Narrative

For the reported event, lot number was provided, and lot history review. The sample was returned for evaluation. Balloon rupture, and peeling pebax was confirmed for the device. A root cause has not been determined. The device was labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model dr8064. Pta balloon dilatation catheter allegedly experienced material rupture and peeled. This report was received from a single source. This event did involve patient with no reported patient injury. Age, weight, and gender were not provided for the patient.

 
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Brand NameDORADO PTA DILATATION CATHETER
Type of DeviceDORADO PTA DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
FUTUREMATRIX INTERVENTIONAL
1605 enterprise street
athens TX 75751
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe , AZ 85281
4803032689
MDR Report Key9597314
Report Number2020394-2020-00517
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 01/16/2020
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 NO INFORMATION
Device MODEL NumberDR8064
Device Catalogue NumberDR8064
Device LOT Number93ND0098
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2019
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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