LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9004 9090410500150

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 2018-01-19 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9004 9090410500150 manufactured by C.r. Bard, Inc. (gfo).

Event Text Entries

[97774094] Analysis: the samples were not returned from the user facility; therefore, the device evaluations are unable to be performed. A lot history review revealed one additional reocclusion complaint was associated with the same patient for this lot. A review of the device history record (dhr) indicates the lot was manufactured to specification. Conclusion: the actual samples were 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, but possibly related to the procedure and definitely related to the av access circuit. 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


[97774095] It was reported through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left cephalic vein of the upper arm. Approximately 2 months after the index procedure, the patient? S left cephalic vein containing the target lesion was reportedly reoccluded. A revascularization was performed and the hcp deemed it was successful. The investigator assessed that the event was not related to the study devices, but possibly related to procedure, and definitely related to av access circuit. The samples were discarded by the user facility and are not available for evaluation. No adverse patient effects were reported. This is one of two products involved with the reported event and the associated manufacturer? S report number is 3006513822-2018-00003.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006513822-2018-00004
MDR Report Key7206508
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2018-01-19
Date of Report2018-04-30
Date of Event2017-12-06
Date Mfgr Received2018-04-06
Device Manufacturer Date2017-03-16
Date Added to Maude2018-01-19
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 Received2018-01-19
Model Number9004
Catalog Number9090410500150
Lot NumberGFBP0757
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 2018-01-19

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