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); Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.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 (1) malfunction event.A review of the events indicated that model cq7594 pta balloon dilatation catheter allegedly experienced an asymmetrical shape during inflation.This report was received from one source.This event involved one patient, age, weight and gender were not provided.This patient had no reported patient injury.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for peeled pebax, fiber disturbance, and deformation of the balloon during inflation.The constricted fibers at the distal cone of the balloon caused the balloon to take the asymmetric shape upon inflation.However, the definitive root cause for the identified fiber constriction or peeled pebax could not be determined based on the available information.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.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the events indicated that model cq7594 pta balloon dilatation catheter allegedly experienced material frayed, peeled layer, and material deformation.This report was received from one source.This event involved one patient, age, weight and gender were not provided.This patient had no reported patient injury.

• 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: 8515267
• Report Number: 2020394-2019-00294
• Device Sequence Number: 1871016
• 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): 07/23/2019

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: CQ7594
• Device Catalogue Number: CQF7594
• Device Lot Number: RECS2855
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1