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

Model Number CQF7584

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunction, the device was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one (1) malfunction.A review of the reported information indicated that model cqf7584 pta balloon dilatation catheter allegedly experienced a deflation issue.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient was (b)(6) lbs.

Event Description

This report summarizes one (1) malfunction.A review of the reported information indicated that model cqf7584 pta balloon dilatation catheter allegedly experienced a deflation issue.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The 81 year old female patient was 212 lbs.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation could not confirm a deflation issue.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6 (results, conclusion) 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
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8822665
• MDR Text Key: 152075992
• Report Number: 2020394-2019-01795
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060557
• UDI-Public: (01)00801741060557
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

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
• Device Operator: No Information
• Device Model Number: CQF7584
• Device Catalogue Number: CQF7584
• Device Lot Number: REDN1447
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/11/2019
• Patient Sequence Number: 1