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

Catalog Number 0224512

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 11/07/2014

Event Type  Injury  

Event Description

It was reported that the valvuloplasty balloon ruptured at 5atm in the left external iliac vein.The balloon detached inside of the patient and surgical intervention was required to retrieve the detached device.The patient was reported as doing well.

Manufacturer Narrative

A complete manufacturing review could not be completed because the lot number was not provided.The device was not returned for evaluation; therefore, the investigation is inconclusive.Per the reported event details, the balloon was being used off-label in the left external iliac vein when it ruptured.The sales rep performed in-servicing at the user facility on (b)(4) 2014.It is likely that the off-label usage of the balloon contributed to the rupture.However, based on the available information the definitive root cause is unknown.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The facility was able to provide new patient information, which was updated in the appropriate sections.

• Brand Name: TRUE DILATATION BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): LOMA VISTA MEDICAL, INC.; 863a mitten road; suite #100a; burlingame CA 94010 1303
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4346041
• MDR Text Key: 5179647
• Report Number: 2020394-2014-00555
• 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,company representative,hea
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0224512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 51 YR
• Patient Weight: 122