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

Model Number	TF0203511
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Insert (1316); Suction Problem (2170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model tf0203511.Balloon valvuloplasty catheter allegedly experienced failure to fold, difficult to insert and aspiration issue.This report was received from a single source.This event did not involve patient with no patient contact.Age, weight, and gender were not provided for the patient.

• Brand Name: TRUE FLOW 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: 8814308
• Report Number: 2020394-2019-01723
• Device Sequence Number: 19234090
• Product Code: OZT
• UDI-Device Identifier: 00801741097652
• UDI-Public: (01)00801741097652
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: TF0203511
• Device Catalogue Number: TF0203511
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1