MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER; BALLOON AORTIC VALVULOPLASTY

Catalog Number	0224512
Medical Device Problem Codes	Leak/Splash (1354); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.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.
Event or Problem Description
It was reported that during an aortic valvuloplasty procedure an alleged air bubble was found inside the balloon during inflation.The balloon was deflated and removed from the patient.A new syringe and stopcock was used but the same issue occurred.A new balloon was prepped and used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.The device was aspirated per the current instructions for use, and the residual air was able to be fully aspirated from the device.No leaks or air bubbles were noted within the device.Therefore, the investigation is unconfirmed for the reported aspiration issue.The definitive root cause for the reported aspiration issue could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the current instructions for use (ifu) states: warnings & precautions: never use force when advancing or retracting intravascular device without first angiographically determining cause for any resistance.Using force may damage catheter or cause injury to the patient (such as vessel perforation).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.Withdrawing balloon through introducer sheath may damage balloon.Dilatation catheter preparation: prior to use, the air in the balloon catheter should be removed.To facilitate purging, select a syringe or inflation device with a 50 ml or larger capacity and fill approximately half of it with the appropriate balloon inflation medium.Do not use air or any gaseous medium to inflate the balloon.Connect a stopcock to the balloon inflation female luer hub on the dilatation catheter.Connect the syringe to the stopcock.Hold the syringe with the nozzle pointing downward, open the stopcock and aspirate for approximately 15 seconds.Release the plunger.Repeat step 7 two more times or until bubbles no longer appear during aspiration (negative pressure).Once completed, evacuate all air from the barrel of the syringe/inflation device.Prepare the wire lumen of the catheter by attaching a syringe to the wire lumen hub and flushing with sterile saline solution.
Event or Problem Description
It was reported that during an aortic valvuloplasty procedure an alleged air bubble was found inside the balloon during inflation.The balloon was deflated and removed from the patient.A new syringe and stopcock was used but the same issue occurred.A new balloon was prepped and used to complete the procedure.There was no reported patient injury.

• Brand Name: TRUE AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
• Common Device Name: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7088276
• Report Number: 2020394-2017-01700
• Device Sequence Number: 11077918
• Product Code: OZT
• UDI-Device Identifier: 00801741091001
• UDI-Public: (01)00801741091001
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K150667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 0224512
• Device Lot Number: GFBR2760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 98