MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE FOCUSED FORCE PTA BALLOON; PTA BALLOON DILATATION CATHETER

Model Number	US14150330
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the device has not been returned for evaluation; therefore, the investigation is inconclusive for retraction problem, failure to advance, and device-device incompatibility as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model us14150330 pta balloon dilatation catheter allegedly experienced failure to advance, device-device incompatibility, and a retraction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The male patient's age and weight were not provided.

• Brand Name: ULTRASCORE FOCUSED FORCE PTA BALLOON
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8809532
• Report Number: 2020394-2019-01635
• Device Sequence Number: 18914049
• Product Code: PNO
• UDI-Device Identifier: 00801741113550
• UDI-Public: (01)00801741113550
• 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): 07/19/2019

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: US14150330
• Device Catalogue Number: US14150330
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1