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

Model Number	0244512
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	07/14/2021
Type of Reportable Event	Death
Event or Problem Description
Balloon deployed and ruptured.When balloon was retracted into sheath, sheath was torn.Balloon and sheath pulled out in tandem casing trauma to iliac artery and subsequent hemorrhage.

• Brand Name: TRUE DILATATION
• Common Device Name: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 12300471
• Report Number: 12300471
• Device Sequence Number: 11874114
• Product Code: OZT
• UDI-Device Identifier: 00801741091018
• UDI-Public: (01)00801741091018(17)230728(10)GFEU3074
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/27/2021
• Report Date (Section F): 07/27/2021

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: 0244512
• Device Catalogue Number: 0244512
• Device Lot Number: GFEU3074
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2021
• 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
• Date Report Sent to FDA: 07/27/2021