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

Catalog Number 0264513

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/19/2015

Event Type  Injury  

Event Description

It was reported that during a pericardiocentesis the valvuloplasty balloon ruptured, detached, and lodged in the pericardium after the third inflation.Pt underwent a surgical intervention (thoracotomy) to remove the balloon fragment.Pt is reportedly doing well.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has not been returned to the mfr for eval.The investigation is currently underway.

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.This file has documentation that attempts were made to the facility to obtain information pertaining to 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).The medwatch 3500a form previously provided represented all known information and no further follow up attempts were completed.

Manufacturer Narrative

A manufacturing review was performed the lot met all release criteria.This is the only complaint reported to date for this lot number, for these issues.The investigation is inconclusive, as the sample was not returned for evaluation.Per the reported event details, the balloon ruptured and detached during a pericardiocentesis the balloon was being used to enlarge the opening in the pericardium.The ifu (instructions for use) states "the true dilatation balloon valvuloplasty catheter is indicated for balloon aortic valvuloplasty." it is likely that the off-label usage of the balloon contributed to the balloon rupture and detachment.Per the reported event details, the doctor was aware that their usage of the balloon was off-label.However, based upon the available information the definitive root cause is unknown.The current ifu (instructions for use) states indications: the true dilatation balloon valvuloplasty catheter is indicated for balloon aortic valvuloplasty.Warnings & precautions: 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.Potential complications/adverse events in the very unlikely event of balloon burst or rupture, balloon could be more difficult to remove through the sheath and could require introducer sheath removal.Potential complications include, but are not limited to.Tissue perforation, conduction system injury, thromboembolic events, hematoma, cardiovascular injury, arrhythmia development, annular or valvular tearing or trauma, restenosis development, inflammation, infection.

• 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: 4541904
• MDR Text Key: 5541404
• Report Number: 2020394-2015-00104
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2015

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: 0264513
• Device Lot Number: PLN001114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: 09/08/2015; 09/08/2015
• Supplement Dates FDA Received: 03/05/2015; 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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
• Patient Outcome(s): Required Intervention