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 Code	Thrombosis (2100)
Date of Event	01/17/2018
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 there is no similar thrombosis 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 possibly related to the study device, to the procedure, and to the av access circuit.Based on the instructions for use (ifu), the occurrence of thrombosis is an inherent risk of any pta procedure.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 catheter was used to treat the target lesion located in the axillary vein in the left upper arm.Approximately 2 months after the index procedure, the patient¿s left axillary vasculature reportedly had a thrombosis.A revascularization involving a thrombectomy was performed and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the study device, to the procedure, and to the av access circuit.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.
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 catheter was used to treat the target lesion located in the axillary vein in the left upper arm.Approximately 2 months after the index procedure, the patient¿s left axillary vasculature reportedly had a thrombosis.A revascularization involving a thrombectomy was performed and the hcp deemed it was successful.The investigator assessed that the event was not related to the study device or to the procedure, but possibly related to the av access circuit.The sample was discarded by the user facility and is 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 3006513822-2018-00068.
Additional Manufacturer Narrative
Additional information: the following statement was added to the end of the event description "this is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2018-00068." corrected data: the event description has had the following sentenced changed from "the investigator assessed that the event was possibly related to the study device, to the procedure, and to the av access circuit." to "the investigator assessed that the event was not related to the study device or to the procedure, but possibly related to the av access circuit." product classification code has been changed from "prc" to "onu." the pma/510(k)# has been changed form "p170003" to "p130024." conclusion the conclusion had the following sentenced changed from "the investigator assessed the event was possibly related to the study device, to the procedure, and to the av access circuit." to "the investigator assessed that the event was not related to the study device or to the procedure, but possibly related to the av access circuit." 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 thrombosis 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 that the event was not related to the study device or to the procedure, but possibly related to the av access circuit.Based on the instructions for use (ifu), the occurrence of thrombosis is an inherent risk of any pta procedure.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.

• 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: 7375701
• Report Number: 3006513822-2018-00067
• Device Sequence Number: 173240
• Product Code: ONU
• UDI-Device Identifier: 00801741088322
• UDI-Public: (01)00801741088322
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: 10/31/2019
• Device Model Number: 9004
• Device Catalogue Number: 9020410600060
• Device Lot Number: GFAX1554
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/23/2018
• 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: 75 YR
• Patient Weight: 78