MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF7564
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the two malfunctions, two lot numbers were provided, and lot history reviews were performed.A device was returned for evaluation for each malfunction; the evaluation did not identify a deflation issue.A root cause has not been determined.The devices were labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model cqf7564 pta balloon dilatation catheter allegedly experienced deflation issue.This information was received from various sources.Each malfunctions involved a patient with no known impact to the patient.One patient was a (b)(6) year-old female weighing (b)(6) lb and the other patient was a (b)(6) year-old female weighing (b)(6) lb.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9596525
• Report Number: 2020394-2020-00456
• Device Sequence Number: 2474452
• Product Code: LIT
• UDI-Device Identifier: 00801741060441
• UDI-Public: (01)00801741060441
• 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): 01/16/2020

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: CQF7564
• Device Catalogue Number: CQF7564
• Device Lot Number: REBW0190, RECV3055
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1