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); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation; therefore, the investigation is inconclusive for material rupture as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that an cq7594 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from one source.The material rupture involved one patient with no patient consequence.The age, weight, and sex were not reported for the patient involved.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that an cq7594 pta balloon dilatation catheter allegedly experienced a material rupture, material frayed, and unraveled material.This information was received from one source.The material rupture involved one patient with no patient consequence.The age, weight, and sex were not reported for the patient involved.
Additional Manufacturer Narrative
One device was returned for evaluation.The lot history review was performed.The investigation confirmed for material rupture, peeled, and unraveled material.A root cause has not been determined.The device is labeled for single use.Device code: 1454.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: 8809666
• Report Number: 2020394-2019-01643
• Device Sequence Number: 10842863
• 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): 10/17/2019

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: CQ7594
• Device Lot Number: RECZ1508
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1