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

Model Number	CQ7588
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The devices for both malfunctions has been returned to the manufacturer for evaluation.For one malfunction, the investigation is confirmed for inflation and deflation issue, however, for another malfunction the investigation is unconfirmed for inflation and deflation.Based upon the available information, the definitive root cause for this event is unknown.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 cq7588 pta dilatation catheter allegedly experienced difficult to inflate and deflation issue.This information was received from various sources.Both malfunctions involved patients with no consequences.Both patient's age, weight and gender were not provided.

• 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: 9596372
• Report Number: 2020394-2020-00445
• Device Sequence Number: 14084785
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138
• 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: CQ7588
• Device Catalogue Number: CQ7588
• Device Lot Number: REDQ4176, REDQ0397
• 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