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	Thrombosis (2100); Pseudoaneurysm (2605)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, a device evaluation was 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 not related to the study device or procedure, but definitely 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.Furthermore, pseudoanuersym is a potential adverse event, per the ifu.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 juxta-anastomotic of the axillary vein in the av fistula of the right upper arm.Approximately 2 months after the index procedure, the patient reportedly had a thrombus within the target lesion.The hcp performed percutaneous transluminal angioplasty (pta) with a surgical revision to explore the venous anastomosis.A thrombectomy involving thrombolysis therapy was performed, but the hcp deemed this treatment to be unsuccessful.Reportedly, residual thrombi with pseudoaneurysm were present after the unsuccessful procedure.The investigator assessed that the event, thrombosis, was not related to the study device or procedure, but definitely related to the av access circuit.The sample was discarded by the user facility and is not available for evaluation.No subsequent adverse patient effects have been reported.
Additional Manufacturer Narrative
Corrected data: product classification code has been changed from "prc" to "onu." the pma/510(k)# has been changed from "p170003" to "p130024." the sample was not returned from the user facility; therefore, a device evaluation was 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 not related to the study device or procedure, but definitely 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.Furthermore, pseudoanuersym is a potential adverse event, per the ifu.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.
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 juxta-anastomotic of the axillary vein in the av fistula of the right upper arm.Approximately 2 months after the index procedure, the patient reportedly had a thrombus within the target lesion.The hcp performed percutaneous transluminal angioplasty (pta) with a surgical revision to explore the venous anastomosis.A thrombectomy involving thrombolysis therapy was performed, but the hcp deemed this treatment to be unsuccessful.Reportedly, residual thrombi with pseudoaneurysm were present after the unsuccessful procedure.The investigator assessed that the event, thrombosis, was not related to the study device or procedure, but definitely related to the av access circuit.The sample was discarded by the user facility and is not available for evaluation.No subsequent adverse patient effects have been 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: 7261317
• Report Number: 3006513822-2018-00022
• Device Sequence Number: 128732
• Product Code: ONU
• UDI-Device Identifier: 00801741088001
• UDI-Public: (01)00801741088001
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 04/30/2018

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: 04/30/2019
• Device Model Number: 9004
• Device Catalogue Number: 9020475600040
• Device Lot Number: GFAR0920
• 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: 02/09/2018
• Supplement Report FDA Received Date: 04/30/2018
• 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: 89 YR
• Patient Weight: 62