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

Catalog Number 0224512

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that the valvuloplasty balloon ruptured during preparation.The device was not used on a patient.Another balloon was used to perform the procedure.There was no patient injury.

Manufacturer Narrative

A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.The device history records have been reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned.The complaint investigation is confirmed for a longitudinal rupture on the barrel of the balloon.Per the ifu, during catheter preparation, air is supposed to be removed from the catheter using standard catheter de-airing techniques.The ifu does not state to inflate the balloon during preparation, as the balloon is only meant to be inflated during use within the patient.Additionally, the complaint comments mention that the user was measuring the balloon with calipers during inflation, which could have contributed to the rupture.The condition of the returned balloon demonstrated a high pressure rupture, indicating that the balloon was over pressurized past its rbp of 6atm.The true dilatation balloon instruction for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.Do not exceed maximum inflation pressure indicated on label.Excess inflation pressure can cause balloon rupture and the inability to withdraw catheter through introducer sheath.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: TRUE DILATATION BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): LOMA VISTA MEDICAL, INC.; 863a mitten road; suite # 100a; burlingame CA 94010 130
• Manufacturer Contact: bryan vogel ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4781437
• MDR Text Key: 20771888
• Report Number: 2020394-2015-00300
• 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: Other
• Type of Report: Initial
• Report Date: 04/01/2014

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 Expiration Date: 10/31/2015
• Device Catalogue Number: 0224512
• Device Lot Number: PLN01412
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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