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

Model Number	CQF5084
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
The lot number was provided; therefore, a lot history review was performed.The sample was not returned and photos were provided for evaluation.The investigation is inconclusive for the reported deflation issue.A definite root cause for the reported event could not be determined.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cqf5084 pta balloon dialation catheter allegedly experienced deflation problem.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DIALATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10286571
• Report Number: 2020394-2020-04518
• Device Sequence Number: 2614010
• Product Code: DQY
• UDI-Device Identifier: 00801741060267
• UDI-Public: (01)00801741060267
• 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): 07/16/2020

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: CQF5084
• Device Catalogue Number: CQF5084
• Device Lot Number: REDX1588
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1