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

Model Number 0244512

Device Problems Retraction Problem (1536); Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 07/14/2021

Event Type  Death  

Event 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Balloon deployed and ruptured.When balloon was retracted into sheath, sheath was torn.Balloon and sheath pulled out in tandem casing trauma to iliac artery and subsequent hemorrhage.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
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 12300471
• MDR Text Key: 265794565
• Report Number: 12300471
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741091018
• UDI-Public: (01)00801741091018(17)230728(10)GFEU3074
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 0244512
• Device Catalogue Number: 0244512
• Device Lot Number: GFEU3074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 33580 DA