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

Model Number	CQF7574
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the two reported malfunctions, both devices were returned for evaluation.The investigation is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes 2 malfunctions.A review of the reported information indicated that model cqf7574 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.Of the 2 ruptures, both did not involve patients.Patient age, weight, and gender was not provided for either patient.
Additional Manufacturer Narrative
H10: of the two reported malfunctions, both devices were returned for evaluation.The two investigations were confirmed for the alleged ruptures, however the root cause could not be determined.The devices are 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 2 malfunctions.A review of the reported information indicated that model cqf7574 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.Of the 2 ruptures, both did not involve patients.Patient age, weight, and gender was not provided for either patient.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model cqf7574 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.Of the 2 ruptures, there was no patient contact.Neither patients' age, weight, or gender were provided.
Additional Manufacturer Narrative
H10: of the two reported malfunctions, both devices were returned for evaluation.Both investigations were confirmed for the alleged rupture issue.One was also confirmed for material deformation, and the other was also confirmed for frayed fibers.Based upon the available information, the definitive root cause for this event is unknown.The devices are 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 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: 8843031
• Report Number: 2020394-2019-02021
• Device Sequence Number: 16208780
• Product Code: LIT
• UDI-Device Identifier: 00801741060496
• UDI-Public: (01)00801741060496
• 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,Followup
• Report Date (Section B): 01/18/2020

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: CQF7574
• Device Catalogue Number: CQF7574
• Device Lot Number: REDP2220,REDP2211
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 10/17/2019; 01/18/2020
• Patient Sequence Number: 1