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	04/11/2018
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 4 additional thrombosis complaints were 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 possibly related to the study device, procedure, and 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.
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 left axillary vein.Approximately 5 months after the index procedure, the patient¿s vessel containing the target lesion reportedly had a thrombosis detected via thrill during a dialysis procedure.A clinically driven revascularization was performed involving placement of a new permcath port, which the heath care professional (hcp) deemed it was successful.The investigator assessed that the event was possibly related to the study device, procedure, and av access circuit.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: event description relationship sentence has changed from the investigator assessed that the event was not related to the study device, but possibly related to the procedure and definitely related to the av access circuit." to "the investigator assessed that the event was possibly related to the study device, procedure, and av access circuit." eval code & desc results code "213" removed due to the changing of the device relationship to the reported event.Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed 4 additional thrombosis complaints were 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 possibly related to the study device, procedure, and 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.
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 left axillary vein.Approximately 5 months after the index procedure, the patient¿s vessel containing the target lesion reportedly had a thrombosis detected via thrill during a dialysis procedure.A clinically driven revascularization was performed involving placement of a new permcath port, which the heath care professional (hcp) deemed it was successful.The hcp has since installed a new shunt for the patient to dialyze through.The investigator assessed that the event was possibly related to the study device, the procedure, and 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 left axillary vein.Approximately 5 months after the index procedure, the patient¿s vessel containing the target lesion reportedly had a thrombosis detected via thrill during a dialysis procedure.The health care professional (hcp) has since installed a new shunt for the patient to dialyze through.A clinically driven revascularization was performed involving a thrombectomy on 01-oct-2018 followed by placement of a new permcath port on 08-oct-2018, which the hcp deemed successful.The investigator assessed that the event was not related to the study device, but possibly related to the procedure and definitely 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.
Additional Manufacturer Narrative
Changed information: b.5.Event description relationship sentence has changed from "the investigator assessed that the event was possibly related to the study device, procedure, and av access circuit." to "the investigator assessed that the event was not related to the study device, but possibly related to the procedure and definitely related to the av access circuit." as well as the following sentence from "a clinically driven revascularization was performed involving placement of a new permcath port, which the heath care professional (hcp) deemed it was successful." to "a clinically driven revascularization was performed involving a thrombectomy on (b)(6) 2018 followed by placement of a new permcath port on (b)(6) 2018, which the hcp deemed successful." b.6.Relevant tests and lab data was changed from "unknown" to "shunt thrombosis treated with thrombectomy on (b)(6) 2018.Permacath placed on (b)(6) 2018." (b)(6).H.3.Conclusion information regarding relationship has changed from "the investigator assessed that the event was possibly related to the study device, procedure, and av access circuit." to "the investigator assessed that the event was not related to the study device, but possibly related to the procedure and definitely related to the av access circuit." h3 analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed 4 additional thrombosis complaints were 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, but possibly related to the procedure and 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.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 left axillary vein.Approximately 5 months after the index procedure, the patient¿s vessel containing the target lesion reportedly had a thrombosis detected via thrill during a dialysis procedure.A clinically driven revascularization was performed involving placement of a new permcath port, which the heath care professional (hcp) deemed it was successful.The hcp has since installed a new shunt for the patient to dialyze through.The investigator assessed that the event was not related to the study device, but possibly related to the procedure and definitely 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.
Additional Manufacturer Narrative
Additional information: b.5.Event description relationship sentence has changed from "the investigator assessed that the event was possibly related to the study device, procedure, and av access circuit." to "the investigator assessed that the event was not related to the study device, but possibly related to the procedure and definitely related to the av access circuit." the following sentence was added "the hcp has since installed a new shunt for the patient to dialyze through." h.6.Eval code & desc - results code added "213".Corrected information: g.1.Mdr contact person and email address was changed from (b)(6) respectively.G.2.Phone number was changed from "(b)(6)".H.3.Conclusion section relationship sentence has changed from "the investigator assessed that the event was possibly related to the study device, procedure, and av access circuit." to "the investigator assessed that the event was not related to the study device, but possibly related to the procedure and definitely related to the av access circuit." h3 analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed 4 additional thrombosis complaints were 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, but possibly related to the procedure and 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.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: 8067184
• Report Number: 3006513822-2018-00263
• Device Sequence Number: 194955
• Product Code: ONU
• UDI-Device Identifier: 00801741135453
• UDI-Public: (01)00801741135453
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/11/2019

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: 01/31/2020
• Device Model Number: 9004
• Device Catalogue Number: 9090475800040
• Device Lot Number: GFBN2471
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 12/20/2018; 01/10/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/11/2018; 01/02/2019; 01/11/2019
• 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: 68 YR
• Patient Weight: 82