MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Reocclusion (1985); Claudication (2550)
Date of Event	09/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed 1 additional complaint for claudication and 3 additional complaints for reocclusion 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.Investigator assessed that the events of both reocclusion and claudication were unlikely related to the study device.Based on the instructions for use (ifu), the occurrence of reocclusion and pain or tenderness are inherent risks of any pta procedure.The occurrence of reocclusion 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.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion in the distal right superficial femoral artery (sfa).Approximately 24 months after the index procedure, the patient¿s right distal sfa vasculature was reported to have no flow during the patients 2 year follow-up with associated mild lower limb claudication.No additional intervention has been performed at this time.A revascularization was performed involving atherectomy, percutaneous transluminal angioplasty (pta), and stent placement, which the hcp deemed it was successful.The investigator assessed that the events of both reocclusion and claudication were unlikely related to the study device.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 7902743
• Report Number: 3006513822-2018-00203
• Device Sequence Number: 1434329
• Product Code: ONU
• UDI-Device Identifier: 00801741088674
• UDI-Public: (01)00801741088674
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 9004
• Device Catalogue Number: 9050613500100
• Device Lot Number: GFZH2963
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 90