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

Catalog Number	0244512
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 facility rep stated that the device was available for evaluation.A sample return kit was sent to the facility and is pending return.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 balloon leak was observed on the balloon.No other information has been provided at this time.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual/microscopic inspection: as received, two true dilation catheters.Product packaging and label for both devices were returned, referencing cat# 0244512 and lot# gfar2825.The samples were randomly numbered and both evaluated as it is unclear which device allegedly failed.Sample 1: visual inspection: the sample appears to be clean.The balloon size for this product is printed on the balloon hub of the catheter and identified the return sample as a 24mm x 4.5cm.No anomalies were noted to the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035" guidewire and it passed without issue.The balloon was inflated to nominal pressure and rbp (6atm) without issues.The balloon then deflated without issues.This test was repeated two additional times, which were both successful.No leaks or any other issues were identified.Sample 2: visual inspection: the sample appears to be clean.The balloon size for this product is printed on the balloon hub of the catheter and identified the return sample as a 24mm x 4.5cm.No anomalies were noted to the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035" guidewire and it passed without issue.The balloon was inflated to nominal pressure and rbp (6atm) without issues.The balloon then deflated without issues.This test was repeated two additional times, which were both successful.No leaks or any other issues were identified.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: two devices were returned.The complaint investigation is unconfirmed for leak, as both balloons inflated without issue during functional testing.The definitive root cause could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported 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.Catheter insertion and balloon inflation: - flush catheter guidewire lumen with saline prior to introducing catheter.- upon reaching and crossing aortic valve, use the = 50 cc inflation syringe or device to inflate balloon to nominal pressure indicated on the package label.Do not exceed maximum inflation pressure indicated on the package label.Balloon deflation and catheter removal: - deflate balloon by drawing vacuum on the = 50 cc inflation device.Use fluoroscopy to visually confirm that balloon has fully deflated prior to withdrawing catheter.- while maintaining negative pressure and guidewire position, withdraw deflated device over the guidewire and out through introducer sheath.Use of a gentle clockwise twisting motion may be used to help withdraw balloon through introducer sheath.- if unusual resistance is met when attempting to withdraw balloon, position balloon in anatomical position in which it can be inflated safely.Partially inflate balloon and then deflate it.Balloon re-folding can be observed under fluoroscopy.Use of recommended contrast concentration will facilitate fluoroscopic visualization of balloon re-folding.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 preparation for an aortic valvuloplasty procedure, an alleged balloon leak was observed on the balloon.There was no reported patient contact.

• Brand Name: TRUE DILATATION BALLOON
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6191261
• Report Number: 2020394-2016-01186
• Device Sequence Number: 16360057
• Product Code: OZT
• UDI-Device Identifier: 00801741091018
• UDI-Public: (01)00801741091018(17)190428(10)GFAR2825
• Combination Product (Y/N): N
• PMA/510(K) Number: K150667
• 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): 11/24/2016

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: 04/28/2019
• Device Catalogue Number: 0244512
• Device Lot Number: GFAR2825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1