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

Model Number	CQF7574
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for the reported inflation and material rupture.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model cqf7574 pta balloon dilatation catheter allegedly inflation problem and material rupture.The information was received from a single source.One patient was involved with no reported patient injury.The (b)(6) year old female patient was (b)(6) kgs.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model cqf7574 pta balloon dilatation catheter allegedly inflation problem and material rupture.The information was received from a single source.One patient was involved with no reported patient injury.The 57 year old female patient was 50 kgs.
Additional Manufacturer Narrative
H10: for the reported malfunctions, reportability was reassessed and determined to be no longer reportable.H10: the lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for the reported inflation and material rupture.Based upon the available information, the definitive root cause for this event 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 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: 10749764
• Report Number: 2020394-2020-06176
• Device Sequence Number: 3457210
• Product Code: DQY
• 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
• Report Date (Section B): 01/08/2021

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: REDP2500
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1