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

Catalog Number TF0243514

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2017

Event Type  malfunction  

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 event reported to date for this lot number and failure mode.Visual inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation was inconclusive, as the sample was not returned for evaluation.The root cause for the reported rupture could not be determined based upon available information.It was unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current instructions for use (ifu) states: warnings: do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over-pressurization, use of a pressure monitoring device is recommended.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation, or cause injury to the patient (such as vessel perforation).Precautions: 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.Use of the true¿ flow valvuloplasty perfusion catheter: position the balloon within the relevant area of the aortic valve to be dilated, ensure the guidewire is in place, and while ensuring the balloon is held in a static position, inflate the balloon to a pressure not greater than rbp.Equipment for use: luer lock syringe/inflation device with manometer (50ml or larger).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 Description

It was reported that post tavr procedure, there was an aortic insufficiency (ai) requiring post dilatation with a valvuloplasty balloon which allegedly ruptured at 12 atm.The balloon was removed and there was no reported retraction difficulty through the sheath.The procedure was completed with another balloon for a successful post tavr bav.There was no reported patient injury.

• Brand Name: TRUE FLOW VALVULPLASTY PERFUSION CATHETER
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6850541
• MDR Text Key: 85642808
• Report Number: 2020394-2017-01094
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741097676
• UDI-Public: (01)00801741097676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/07/2017

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: 12/28/2017
• Device Catalogue Number: TF0243514
• Device Lot Number: GFAZ2995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• 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 Age: 76 YR
• Patient Weight: 150