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

Model Number	US35130512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Upon receipt of new or additional information and completion of investigation, a follow-up report will be submitted as applicable.(expiration date: 06/2020).
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure in the superial femoral artery with a focused forced percutaneous transluminal angioplasty (pta) balloon dilatation catheter, following use of the study device, stent was placed for elastic recoil in mid sfa.
Additional Manufacturer Narrative
The purpose of this supplement is to report that the event is no longer reportable.The site determined that the event was not related to the device or the procedure; therefore, the ae was removed.As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Upon receipt of new or additional information and completion of investigation, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure in the superial femoral artery with a focused forced percutaneous transluminal angioplasty (pta) balloon dilatation catheter, following use of the study device, stent was placed for elastic recoil in mid sfa.

• 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: 8742132
• Report Number: 2020394-2019-01285
• Device Sequence Number: 14112854
• Product Code: PNO
• UDI-Device Identifier: 00801741116780
• UDI-Public: (01)00801741116780
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: US35130512
• Device Catalogue Number: US35130512
• Device Lot Number: GFCR3318
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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: CLOPIDOGREL; CLOPIDOGREL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR