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

Model Number	CQF7574
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, 4 out of the 4 devices were returned to bd for evaluation.The lot numbers for 4 out of 4 were provided, and lot history reviews were performed.After further evaluation, the investigation did not identify the reported deflation problem for all of the 4 devices.The definitive root cause could not be determined based upon available information.The devices are labeled for single use.
Event or Problem Description
This report summarizes four malfunctions.A review of the malfunctions indicated that model cqf7574 pta balloon dilatation catheter allegedly experienced deflation issues.This report was received from various sources.The malfunctions involved 4 patients with no patient consequences.The four patients ranged from 58-68 years of age and weight range 165-194 lb.Of the reported patients 2 were males and 2 were female.

• 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: 9596757
• Report Number: 2020394-2020-00472
• Device Sequence Number: 2387477
• 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
• Report Date (Section B): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CQF7574
• Device Catalogue Number: CQF7574
• Device Lot Number: REDU4267, REDS2031, REDN4424
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1