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

Model Number	CQ7594
Medical Device Problem Codes	Material Frayed (1262); Inflation Problem (1310); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was returned for evaluation.The company is still investigating the issue at this time.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cq7594 pta dilatation catheter allegedly experienced inflation problem, material frayed, material deformation, and unraveled material.This information was received from one source.Of the one malfunction, one patient was involved with no patient consequence or impact.Patient age, weight, and gender was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was returned for evaluation.The investigation is confirmed for the reported inflation issue, balloon rupture, frayed fibers and fiber disturbance.A root cause has not been determined.The device was 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cq7594 pta dilatation catheter allegedly experienced inflation problem, material frayed and material rupture.This information was received from one source.Of the one malfunction, one patient was involved with no patient consequence or impact.Patient age, weight, and gender was 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: 9596462
• Report Number: 2020394-2020-00450
• Device Sequence Number: 11387633
• Product Code: DQY
• UDI-Device Identifier: 00801741063190
• UDI-Public: (01)00801741063190
• 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): 04/03/2020

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: CQ7594
• Device Catalogue Number: CQ7594
• Device Lot Number: REDR2107
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1