MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION BALLOON

Catalog Number 0244512

Device Problem Difficult to Remove (1528)

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

Event Date 03/24/2015

Event Type  malfunction  

Event Description

It was reported that the balloon valvuloplasty catheter was difficult to remove through the sheath; therefore, the catheter and sheath were removed together as a single unit.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review could not be performed as the lot number is unk.The device has not been returned to the manufacturer for evaluation.The investigation is currently underway.A-d: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complaint/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: TRUE DILATATION BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): LOMA VISTA MEDICAL, INC.; 863a mitten rd.; ste #100a; burlingame CA 94010 130
• Manufacturer Contact: george james ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4731210
• MDR Text Key: 5739501
• Report Number: 2020394-2015-00526
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2015

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: Health Professional
• Device Catalogue Number: 0244512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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