MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTS BALLOON DILATATION CETHETER

Catalog Number U357554

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

It was reported that during flushing of the wire lumen, the saline solution exited from the balloon port.Another balloon was used to complete the procedure.There was no patient involvement.

Manufacturer Narrative

A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.The information provided by bard 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 bard.

• Brand Name: ULTRAVERSE 035 PTS BALLOON DILATATION CETHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscothy, co.; wexford 85281 ; EI 85281
• Manufacturer Contact: brett curtice ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4780972
• MDR Text Key: 5860006
• Report Number: 2020394-2015-00381
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: U357554
• Device Lot Number: 50114024
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1