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

Catalog Number 02444512

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2014

Event Type  Injury  

Event Description

It was reported that the valvuloplasty balloon would not deflate.The balloon was retracted through the aortic valve with difficulty into the upper arch.The balloon was then deflated with negative pressure.There was no reported retraction difficulty through the sheath.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review was conducted.The lot met all release criteria.This is the only complaint reported to date for this lot number for this issue.The device was returned.The investigation is unconfirmed for deflation issues, as the device was able to deflate with no issues during the evaluation.The patency of the guidewire lumen was tested using an in-house 0.035" guidewire, and it passed without issue.The balloon was then inflated with water using an in-house inflation device in order to functionally test the device per the ifu.The balloon was inflated to rated burst pressure (6 atm), and then deflated without issue.This test was performed an additional two times yielding the same results.The investigation is inconclusive for difficult to remove from the aortic valve, as the reported conditions of use could not be recreated (i.E.Patient aortic valve).The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.

Manufacturer Narrative

There was no known impact or consequence to the patient, however, as the balloon would not deflate while in the patient's heart, the risk to the patient is considered high.After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a serious injury.

Manufacturer Narrative

Voluntary report no mw5039715 was received.

Event Description

It was reported that the valvuloplasty balloon would not deflate.The hcp reported that the balloon was retracted through the aortic valve with alleged difficulty into the upper arch.The hcp further reported that once the balloon was in the upper arch, negative pressure was applied for 70 seconds allowing for the balloon to deflate and allegedly be retracted through the aortic root.There was no reported retraction difficulty through the sheath.There was no known impact or consequence to pt.Ref mw5039715.

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.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
• Type of Device: OZT
• 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
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4350998
• MDR Text Key: 5143393
• Report Number: 2020394-2014-00567
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• PMA/PMN Number: K121083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

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 Expiration Date: 03/31/2015
• Device Catalogue Number: 02444512
• Device Lot Number: PLN02273
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/08/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 105