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

Catalog Number CQF75104

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Event Description

Conquest 40 pta dilatation catheter balloon attempted to be used in tips (transjugular intrahepatic portosystemic shunt) revision would not load over an 035 wire.Had to use new balloon.The patient was not harmed.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Type of Device: BALLOON, CATHETER, DILATOR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 5340104
• MDR Text Key: 34907570
• Report Number: 5340104
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: CQF75104
• Device Lot Number: REZJ0099
• Other Device ID Number: 10MM X 4CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1