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

Model Number CQ7564

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device and a photo have been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq7564 pta balloon dilatation catheter allegedly experienced a device markings/labelling problem.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq7564 pta balloon dilatation catheter allegedly experienced a device markings/labelling problem.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device and a photo was returned to the manufacturer for evaluation.The investigation is confirmed for the reported inflation hub mislabeling.The definitive root cause for the reported mislabeling could not be determined based upon available information.The device is labeled for single use.H10: g4, h11: g1, 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.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 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: 9967933
• MDR Text Key: 188081336
• Report Number: 2020394-2020-02837
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062902
• UDI-Public: (01)00801741062902
• 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: 07/02/2020

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
• Device Operator: No Information
• Device Model Number: CQ7564
• Device Catalogue Number: CQ7564
• Device Lot Number: REDU2646
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/02/2020
• Patient Sequence Number: 1