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

Catalog Number	TF0223512
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2017
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 investigation is currently under way.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, the x-ray markers on the balloon were allegedly not visible while attempting to position the balloon.Reportedly, the balloon was successfully retracted out of the patient and the health care provider checked for markers but no markers were visible.Another balloon was 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.Visual/microscopic inspection: the balloon size was printed on the balloon hub of the catheter and identified the returned sample as a 22mm x 3.5cm balloon.The balloon appeared to have been previously inflated.No other anomalies were observed.Functional/performance evaluation: the balloon was cut at the legs in order to determine whether the marker bands were present.Upon opening the balloon, both marker bands were missing from the inner catheter.No glue marks were identified to the inner shaft at the location of where the marker bands should have been placed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: the balloon was examined via x-ray imaging prior to functional testing, and the marker bands were not visible.Conclusion: the sample was returned.The investigation is confirmed for component missing, as the x-ray markers were absent upon evaluation.This is a confirmed manufacturing related issue.An ongoing internal investigation was opened to further investigate the issue and determine any corrective and preventative actions that are needed.However, the definitive root cause for the missing marker bands is unknown.Labeling review: the current instructions for use (ifu) states: warnings: - catheter balloon inflation diameter must be carefully considered in selecting a particular size for any patient.It is critical to perform a clinical diagnostic determination of valve anatomical dimensions prior to use; imaging modalities such as transthoracic echocardiogram (tte), computerized tomography (ct), angiography, and/or transesophageal echocardiogram (tee) should be considered.The inflated balloon diameter should not be significantly greater than valvular diameter.- 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: - carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.- dilation procedures should be conducted under high-quality fluoroscopic guidance.Use of the true¿ flow valvuloplasty perfusion catheter: - position the balloon within the relevant area of the aortic valve to be dilated, ensure.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, the x-ray markers on the balloon were allegedly not visible while attempting to position the balloon.Reportedly, the balloon was successfully retracted out of the patient and the health care provider checked for markers but no markers were visible.Another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: TRUE FLOW VALVULOPLASTY PERFUSION CATHETER
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6314082
• Report Number: 2020394-2017-00051
• Device Sequence Number: 10947006
• Product Code: OZT
• UDI-Device Identifier: 00801741097669
• UDI-Public: (01)00801741097669(17)171028(10)GFAX3477
• Combination Product (Y/N): N
• PMA/510(K) Number: K152613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2017
• Device Catalogue Number: TF0223512
• Device Lot Number: GFAX3477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR