MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018; PTA BALLOON DILATATION CATHETER

Model Number	U820084
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	12/21/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported through the litigation process that a balloon expandable stent was placed in a patient after being diagnosed with hypertension, cachexia, unstable angina, and heavily calcified left anterior descending artery lesion.At some time, post stent deployment, it was alleged that the device was difficult to be removed after an unsuccessful percutaneous removal procedure and material deformed.The patient reportedly expired due to cardiac arrest, post percutaneous coronary intervention ventricular fibrillation arrest and heart failure.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not 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.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.H3 other text : device not returned.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a death.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 litigation process that a balloon was used in a patient after being diagnosed with hypertension, cachexia, unstable angina, and heavily calcified left anterior descending artery lesion.Multiple balloons were used to place the stent and at some time post the stent deployment, the patient was deceased due to the cardiac arrest, post percutaneous coronary intervention ventricular fibrillation arrest and the heart failure.There were no balloon related technical difficulties identified within the provided medical records.The patient was reportedly expired.

• Brand Name: ULTRAVERSE 018
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17132887
• Report Number: 2020394-2023-00429
• Device Sequence Number: 6400297
• Product Code: LIT
• UDI-Device Identifier: 00801741165108
• UDI-Public: (01)00801741165108
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K192318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: U820084
• Device Catalogue Number: U820084
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN, NITROGLYCERIN, ATORVASTATIN CALCIUM; ASPIRIN, NITROGLYCERIN, ATORVASTATIN CALCIUM; ISOSORBIDE MONONITRATE AND METOPROLOL SUCCINATE; ISOSORBIDE MONONITRATE AND METOPROLOL SUCCINATE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White