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

Model Number	CQF7582
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.Photos of the device have been provided for review.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that the package labeling for a model cqf7582 pta balloon dilatation catheter allegedly did not match the device inside the package.This information was received from a single source.There was no patient contact.The patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cqf7584 pta balloon dilatation catheter allegedly experienced a device marking/labelling problem.This information was received from one source.There was no patient contact.No patient information was provided.
Additional Manufacturer Narrative
The malfunction reported on this file was updated from cqf7582 to cqf7584.The lot number for the malfunction was provided and a lot history review was performed.The device and a photo has been returned for evaluation; the device and photo evaluation confirm a labelling issue.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 8822591
• Report Number: 2020394-2019-01793
• Device Sequence Number: 3206312
• Product Code: DQY
• UDI-Device Identifier: 00801741060533
• UDI-Public: (01)00801741060533
• 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,Followup
• Report Date (Section B): 10/11/2019

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: CQF7582
• Device Catalogue Number: CQF7584
• Device Lot Number: REDQ3444
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1