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

Model Number CQ7574

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided; therefore, a lot history review will be performed.The return of the sample is pending and the investigation for the reported event is currently underway.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq7574 pta dilatation catheter allegedly experienced inflation and deflation problem.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cq7574 pta dilatation catheter allegedly experienced inflation and deflation problem.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

Manufacturer Narrative

The lot number was provided; therefore, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for the reported inflation issue however,the investigation is inconclusive for reported unable to deflate and difficult to remove issues.A definitive root cause could not be determined.The device was 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 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: 10286844
• MDR Text Key: 199251360
• Report Number: 2020394-2020-04560
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062995
• UDI-Public: (01)00801741062995
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQ7574
• Device Catalogue Number: CQ7574
• Device Lot Number: REDX0241
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1