LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9004 9020475600040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-02-06 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9004 9020475600040 manufactured by C.r. Bard, Inc. (gfo).

Event Text Entries

[99187126] Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed. A lot history review revealed there is no similar reocclusion complaints associated with this lot. A review of the device history record (dhr) indicates the lot was manufactured to specification. Conclusion: the actual sample was not received for evaluation. The dhr found nothing to indicate a manufacturing related cause for this event. The investigator assessed the event was not related to the study device or procedure. Based on the instructions for use (ifu), the occurrence of reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons. If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10


[99187127] It was reported through a clinical registry that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left cephalic vein arch. Approximately 3 months after the index procedure, the patient? S left cephalic vessel was reportedly reoccluded, which decreased the blood flow to the av fistula. A revascularization was performed and the hcp deemed it was successful. The investigator assessed that the event was not related to the study device or procedure. The sample was discarded by the user facility and is not available for evaluation. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006513822-2018-00020
MDR Report Key7246757
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2018-02-06
Date of Report2018-04-30
Date of Event2017-12-15
Date Mfgr Received2018-04-06
Device Manufacturer Date2016-05-13
Date Added to Maude2018-02-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOHN RISSE
Manufacturer Street9409 SCIENCE CENTER DR
Manufacturer CityNEW HOPE MN 55428
Manufacturer CountryUS
Manufacturer Postal55428
Manufacturer Phone7634632917
Manufacturer G1C.R. BARD, INC. (GFO)
Manufacturer Street289 BAY ROAD
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal Code12804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLUTONIX 035 DRUG COATED BALLOON PTA CATHETER
Generic NameDRUG COATED BALLOON PTA CATHETER
Product CodePRC
Date Received2018-02-06
Model Number9004
Catalog Number9020475600040
Lot NumberGFAR0920
Device Expiration Date2019-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (GFO)
Manufacturer Address289 BAY ROAD QUEENSBURY NY 12804 US 12804


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-02-06

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