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

Catalog Number	0244512
Medical Device Problem Code	Aspiration Issue (2883)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/17/2017
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 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 preparation for an aortic valvuloplasty procedure the balloon catheter allegedly aspirated while pulling negative pressure.Another balloon was used to perform the procedure.There was no patient contact.
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.Visual/microscopic inspection: as the sample was not returned for evaluation, a visual/microscopic inspection could not be performed.Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed.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: the investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause for the reported aspiration issue 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.Withdrawing balloon through introducer sheath may damage balloon.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.If balloon will not pass through introducer sheath for removal, remove balloon and sheath as a single unit.
Event or Problem Description
It was reported that during preparation for an aortic valvuloplasty procedure the balloon catheter allegedly aspirated while pulling negative pressure.Another balloon was used to perform the procedure.There was no patient contact.

• Brand Name: TRUE DILATATION BALLOON VALVULOPLASTY CATHETER
• Common Device Name: VALVULOPLASTY BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6786862
• Report Number: 2020394-2017-00949
• Device Sequence Number: 11225936
• Product Code: OZT
• UDI-Device Identifier: 00801741091018
• UDI-Public: (01)00801741091018
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 05/28/2019
• Device Catalogue Number: 0244512
• Device Lot Number: GFAR2828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1