MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER

Model Number	0234512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/25/2020
Type of Reportable Event	Death
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.(expiry date: 12/2022).
Event or Problem Description
It was reported that following valvuloplasty procedure, the patient experienced loss of consciousness and cardio-pulmonary arrest, which required cardiopulmonary resuscitation (cpr).It was further reported that aortography confirmed severe aortic insufficiency (ai), however, after implantation of biologic aortic valve, ventricular fibrillation (vf) was resistant to defibrillation and cpr.Reportedly, the patient expired.There was no device deficiency or malfunction.

• Brand Name: TRUE DILATATION CATHETER
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9794980
• Report Number: 2020394-2020-01264
• Device Sequence Number: 16716472
• Product Code: OZT
• UDI-Device Identifier: 00801741097454
• UDI-Public: (01)00801741097454
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 0234512
• Device Catalogue Number: 0234512
• Device Lot Number: GFDZ2392
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death