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

Model Number	US14150220
Medical Device Problem Codes	Retraction Problem (1536); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided, therefore the lot history review has been performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the reported issue.The definitive root cause could not be established.The device is labeled for singe use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model us14150220 pta balloon dilatation catheter allegedly experienced retraction problems and device-device incompatibility.This information was received from one source.One patient was involved and there was no reported patient injury.The male patient is 77 years old and weight was 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: 9200124
• Report Number: 2020394-2019-04036
• Device Sequence Number: 306123
• Product Code: PNO
• UDI-Device Identifier: 00801741113338
• UDI-Public: (01)00801741113338
• 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): 10/16/2019

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: US14150220
• Device Catalogue Number: US14150220
• Device Lot Number: GFDQ2520
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1