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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number DR13568
Device Problems Peeled / Delaminated; Material Rupture
Event Type  Malfunction  
Manufacturer Narrative

The sample was returned for evaluation. The sample was appeared to be clean. No kinks or anomalies to the luers, bifurcate or glue fillets. Peeled pebax was noted to the balloon approx. 9. 3cm from the distal tip. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model dr13568 pta balloon dilatation catheter allegedly experienced delamination and a material rupture. This information was received from a single source. The alleged malfunction involved a patient with no known impact to the patient. The patient was reported to be (b)(6), weight and gender were not provided.

 
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Brand NameDORADO 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)
FUTUREMATRIX INTERVENTIONAL
1605 enterprise street
athens TX 75751
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key8811695
Report Number2020394-2019-01652
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberDR13568
Device Catalogue NumberDR13568
Device LOT Number93VC0075
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
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 Initial

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