MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA BALLOON DILATATION CATHETER

Model Number	U41502H15RX
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of a retrospective review of events that occurred in japan and in accordance with 21 c.F.R.Part 803, this event was assessed and determined to be mdr reportable.No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 in preparation for a procedure, the proximal side of the pta balloon allegedly would not deflate.There was no reported patient contact.
Additional Manufacturer Narrative
As a result of a retrospective review of events that occurred in (b)(6) and in accordance with 21 c.F.R.Part 803, this event was assessed and determined to be mdr reportable.Manufacturing review: the device history records have been reviewed and 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 not returned, however three electronic photos were provided for review.The investigation is inconclusive for the reported issue, as the photo review could not confirm a deflation issue and the sample was not returned for full functional evaluation of the device.The definitive root cause for the reported deflation issue could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and introducer sheath/guide catheter as a single unit.Potential adverse reactions: additional intervention.
Event or Problem Description
It was reported that in preparation for a procedure, the proximal side of the pta balloon allegedly would not deflate.There was no reported patient contact.

• Brand Name: ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6813415
• Report Number: 2020394-2017-01005
• Device Sequence Number: 11205513
• Product Code: LIT
• UDI-Device Identifier: 00801741056628
• UDI-Public: (01)00801741056628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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: 07/31/2017
• Device Model Number: U41502H15RX
• Device Catalogue Number: U41502H15RX
• Device Lot Number: 50110372
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1