MAUDE Adverse Event Report: BARD CONQUEST; PTA BALLOON DILATATION CATHETER

Catalog Number CQ-7584

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

Balloon could not be threaded over the wire.There seemed to be an occlusion within the balloon that prevented the threading.Procedure was delayed in getting another balloon.

• Brand Name: CONQUEST
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD; tempe AZ 85281
• MDR Report Key: 4253556
• MDR Text Key: 5012190
• Report Number: MW5039066
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: CQ-7584
• Device Lot Number: REYG1209
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR