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	Stenosis (2263); Vascular Dissection (3160)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Label 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: 05/2021).
Event or Problem Description
It was reported through the results of a clinical trial during angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the right superficial femoral artery, dissection type b was identified and a stent was placed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Label review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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 during angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the right superficial femoral artery, dissection type b was identified and a stent was placed.There was no reported patient injury.New information: approximately 6.5 months post index procedure, the target lesion was experiencing 50-99% stenosis.No medical re-intervention has been performed.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Label review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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 during an angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilatation catheter in the right superficial femoral artery, type b dissection was identified and a stent was placed.Approximately 6.5 months post index procedure, the target lesion was experiencing 50-99% stenosis.Approximately seven months post index procedure, the target lesion and target vessel were successfully treated with standard pta.The subject completed the study.

• 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: 9261676
• Report Number: 2020394-2019-04343
• Device Sequence Number: 3730792
• 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
• Report Date (Section B): 07/31/2020

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: US35130515
• Device Catalogue Number: US35130515
• Device Lot Number: GFDR2034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 01/31/2020; 07/28/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 02/06/2020; 07/31/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 88