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

Model Number	0184511
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During post dilatation, the true balloon ruptured.

• Brand Name: TRUE DILATATION
• Common Device Name: CATHETER, DILATATION, BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st; tempe AZ 85281
• MDR Report Key: 7800519
• Report Number: 7800519
• Device Sequence Number: 1143590
• Product Code: EZN
• UDI-Device Identifier: 00801741097430
• UDI-Public: (01)00801741097430
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/10/2018
• Report Date (Section F): 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 0184511
• Device Catalogue Number: 0184511
• Device Lot Number: GFCQ2696
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/10/2018