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

Model Number	CQF7564
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
A lot history review was conducted and it was determined that a device history record (dhr) review was not required.Device was returned or evaluation.A visual inspection did not find any kinks or anomalies to the device.Device was inflated to nominal pressure and rbp and deflated without issue within 9 seconds.Therefore, the investigation is unconfirmed for the reported deflation issue.The definitive root cause for the reported balloon deflation issue could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cqf7564 pta balloon dilatation catheter allegedly had a deflation issue.There was no reported patient injury.This information was received from one source.The patient was a (b)(6) year-old female who weighed (b)(6) pounds.

• 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: 8817172
• Report Number: 2020394-2019-01755
• Device Sequence Number: 457393
• Product Code: DQY
• UDI-Device Identifier: 00801741060441
• UDI-Public: (01)00801741060441
• 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): 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: CQF7564
• Device Catalogue Number: CQF7564
• Device Lot Number: RECV3055
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1