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

Model Number	CQ5062
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, the cq5062 crosser pta balloon dilatation catheter was returned to the manufacturer for evaluation.The investigation identified a detachment.The investigation was not able to determine a root cause.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the events indicated that model cq5062 pta balloon dilatation catheter experienced a detachment.This report was received from one source.The device was used in the patient.The patient is a male weighing (b)(6) kgs.Patient age was not provided.There was no reported patient injury.

• Brand Name: CONQUEST 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: 8808308
• Report Number: 2020394-2019-01621
• Device Sequence Number: 13533189
• Product Code: DQY
• UDI-Device Identifier: 00801741062865
• UDI-Public: (01)00801741062865
• 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: CQ5062
• Device Catalogue Number: CQ5062
• Device Lot Number: REBW2000
• 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