MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE FOCUSED FORCE PTA BALLOON

Model Number	US35130515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Stenosis (2263)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 08/2020).
Event or Problem Description
It was reported through the results of a clinical trial that approximately three-month post angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the right superficial femoral artery, ultrasound demonstrated stenosis in the target lesion.It was further reported that drug coated balloon and atherectomy were used to treat the lesion result in successful procedure.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported through the results of a clinical trial that approximately three-month post angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the left superficial femoral artery, ultrasound demonstrated stenosis in the target lesion.It was further reported that drug coated balloon and atherectomy were used to treat the lesion result in successful procedure.New information: approximately 7 months post index procedure, intravascular ultrasound and an atherectomy were performed as re-intervention to the left superficial artery that had an 80% concentric calcific lesion at the midportion.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported through the results of a clinical trial that approximately three-month post angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the left superficial femoral artery, ultrasound demonstrated stenosis in the target lesion.It was further reported that drug coated balloon and atherectomy were used to treat the lesion result in successful procedure.New information: approximately 7 months post index procedure, intravascular ultrasound and an atherectomy were performed as re-intervention to the left superficial artery that had an 80% concentric calcific lesion at the midportion.New information: approximately 7 months post index procedure, an atherectomy and pta were used as treatment in the target lesion which reduced stenosis from 59% to 10%.New information: it was reported through the results of a clinical trial that during 12-month follow-up visit, duplex ultrasound was performed and 50-90% stenosis was identified.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported through the results of a clinical trial that approximately three-month post angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the left superficial femoral artery, ultrasound demonstrated stenosis in the target lesion.It was further reported that drug coated balloon and atherectomy were used to treat the lesion result in successful procedure.New information: approximately 7 months post index procedure, intravascular ultrasound and an atherectomy were performed as re-intervention to the left superficial artery that had an 80% concentric calcific lesion at the midportion.New information: approximately 7 months post index procedure, an atherectomy and pta were used as treatment in the target lesion which reduced stenosis from 59% to 10%.

• Brand Name: ULTRASCORE FOCUSED FORCE PTA BALLOON
• Common Device Name: FOCUSED FORCE PTA BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8841863
• Report Number: 2020394-2019-02017
• Device Sequence Number: 205839
• Product Code: PNO
• UDI-Device Identifier: 00801741116797
• UDI-Public: (01)00801741116797
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K163420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/19/2020

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 Model Number: US35130515
• Device Catalogue Number: US35130515
• Device Lot Number: GFCV3189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 02/19/2020; 05/12/2020; 06/17/2020
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 02/20/2020; 05/13/2020; 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN, CLOPIDOGREL; ASPIRIN, CLOPIDOGREL; ASPIRIN, CLOPIDOGREL; ASPIRIN, CLOPIDOGREL; ASPIRIN, CLOPIDOGREL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR