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

Model Number	US3513054
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	12/12/2018
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 instructions for use (ifu) is adequate for the reported device/patient code(s) 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 during an angioplasty procedure with a focused force percutaneous transluminal angioplasty (pta) balloon dilatation catheter, vessel dissection was identified in the superficial femoral artery.It was further reported a bare metal stent was placed at the targeted lesion.Patient was discharged one day post index procedure.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty (pta) balloon dilatation catheter, vessel dissection was identified in the superficial femoral artery.It was further reported a bare metal stent was placed at the targeted lesion.Patient was discharged one day post index procedure.New information: it was reported that approximately 6 months post index procedure, target lesion stenosis was allegedly identified via imaging.It was further reported that re-intervention was performed with successful result.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.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.Additional narrative: date received by mfr; adverse event; description of event or problem.Mfr site, mfr name, city & state.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.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.H10: b6, b7, g4 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 during an angioplasty procedure with a focused force percutaneous transluminal angioplasty (pta) balloon dilatation catheter, vessel dissection was identified in the superficial femoral artery.It was further reported a bare metal stent was placed at the targeted lesion.Patient was discharged one day post index procedure.New information: it was reported that approximately 5 months post index procedure, target lesion stenosis was allegedly identified via imaging.No re-intervention was performed.New information: it was reported that approximately 6 months post index procedure, target lesion stenosis was allegedly identified via imaging.It was further reported that re-intervention was performed with successful result.

• 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: 8384086
• Report Number: 2020394-2019-00161
• Device Sequence Number: 19330493
• Product Code: PNO
• UDI-Device Identifier: 00801741116742
• UDI-Public: (01)00801741116742
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2020

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: US3513054
• Device Catalogue Number: US3513054
• Device Lot Number: GFCV2112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 12/26/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 12/10/2019; 01/02/2020
• 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: ASPIRINCLOPIDOGREL; ASPIRINCLOPIDOGREL; ASPIRINCLOPIDOGREL; ASPIRINCLOPIDOGREL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 85