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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
Catalog Number UNKNOWN DR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.
 
Event Description
It was reported through the results of a clinical trial, that approximately five months post index procedure, the patient developed 80 % of target lesion stenosis.A standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The patient was expired due to end stage renal disease and the cause of death was not related to the device.
 
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Brand Name
DORADO PTA DILATATION CATHETER
Type of Device
PTA 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 75751
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12457616
MDR Text Key270999499
Report Number2020394-2021-01669
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072283
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Physician
Type of Report Initial
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN DR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age81 YR
Patient Weight51
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