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

Model Number	CQ75124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, the devices were returned to bd and evaluated.The photo review is currently underway review.The company is still investigating the issue at this time.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 cq75124 pta balloon dilatation catheter allegedly experienced break.This report was received from a single source.This event did not involve patient with no patient contact.Age, weight, and gender were not provided for the patient.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cq75124 pta balloon dilatation catheter allegedly experienced break.This report was received from a single source.This event did not involve patient with no patient contact.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was returned; however a photo has been provided and reviewed.The investigation and photo review was confirmed for the device break.The definitive root cause is unknown.The device is labeled for single use.H11: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 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: 9967637
• Report Number: 2020394-2020-02823
• Device Sequence Number: 19792223
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• 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): 07/23/2020

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: CQ75124
• Device Catalogue Number: CQ75124
• Device Lot Number: REDT4041
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1