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

Model Number	US141503H30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Vascular Dissection (3160)
Date of Event	04/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and a lot history review was performed.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiration date: 04/2021).
Event or Problem Description
It was reported through the results of a clinical study trial, a focused force pta balloon was used to treat the left femoral artery and dissection was identified.It was further reported that approximately 6-month post index procedure, occlusion was identified via duplex ultrasound.It was further reported that the medical intervention was required to treat the patients.The current status of the patients is unknown.

• Brand Name: ULTRASORE 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: 10322302
• Report Number: 2020394-2020-05097
• Device Sequence Number: 2979065
• Product Code: PNO
• UDI-Device Identifier: 00801741113659
• UDI-Public: (01)00801741113659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172571
• 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
• Report Date (Section B): 07/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: US141503H30
• Device Catalogue Number: US141503H30
• Device Lot Number: GFDR1940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/24/2020
• 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: CLOPIDOGREL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 60