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

Catalog Number 0204511

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

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

Event Date 02/10/2015

Event Type  Injury  

Event Description

It was reported that the valvuloplasty balloon guard was introduced into the patient and lodged within the left ventricle.Patient underwent additional medical intervention (use of a snare device) to remove the balloon guard from the left ventricle.No known impact or consequence to patient.Patient 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 manufacturer for evaluation.The investigation is currently underway.

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 this issue.The investigation is inconclusive, as the sample was not returned for eval.Per the reported event details, the balloon guard was introduced into the pt.Per the current ifu, the balloon guard needs to be kept on the balloon until removing it immediately prior to inserting the catheter into the introducer.As the balloon guard was not removed from the balloon prior to inserting the catheter into the introducer, the root cause is user related.Specific warnings, precautions and directions for use of the true dilatation balloon catheter are included in the current ifu.

Manufacturer Narrative

The event was reported via medwatch report #5040921.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.; 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: 4613477
• MDR Text Key: 5653781
• Report Number: 2020394-2015-00137
• 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,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 0204511
• Device Lot Number: PLN02802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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): Life Threatening; Required Intervention