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

Catalog Number	U4150525RX
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
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 as a malfunction.No medical records or no medical images have been made available to the manufacturer; however, a photo was provided.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 during an angioplasty procedure using a contralateral approach with increasing dilating pressure, the pta balloon catheter allegedly broke when it was advanced across the vessel with force.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: one electronic photo was reviewed.The device is coiled and the entire balloon was visibly detached from the proximal end of the device, at the rapid exchange port.Based on the photo provided, the a detached balloon can be confirmed.It is likely that the user perceived the detachment as a break.Conclusion: the device was not returned, however, one photo was provided.Based on the photo review, the investigation is confirmed for a balloon detachment.It is likely the user perceived the detachment as a break.Per the reported event details, the device was advanced forcibly across the vessel.Therefore, it is possible that procedural issues contributed to the reported detachment.However, the definitive root cause could not be determined based upon available information.Labeling review: the current (b)(6) ifu (instructions for use) states: warnings: - to prevent vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis.Select a balloon size so that its inflated balloon diameter does not exceed the minimum vessel diameter when diameters of a target vessel vary.[or, it can cause vessel injury.] - 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 cause vessel damage and the catheter can result in tip or catheter breakage, catheter kink or balloon separation.] - do not exceed the rbp recommended for this device.To prevent over pressurization, use of inflation device with manometer is recommended.[balloon rupture may occur if the rbp rating is exceeded.] - careful attention must be paid to the dilatation of calcified lesions or tortuous anatomy.[it may lead to catheter damage or balloon rupture.Prohibitions: - do not reuse.- do not resterilize.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 during an angioplasty procedure using a contralateral approach with increasing dilating pressure, the pta balloon catheter allegedly broke when it was advanced across the vessel with force.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA 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: 6457371
• Report Number: 2020394-2017-00305
• Device Sequence Number: 16284458
• Product Code: LIT
• UDI-Device Identifier: 00801741058004
• UDI-Public: (01)00801741058004(17)181130(10)50132783
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: 11/30/2018
• Device Catalogue Number: U4150525RX
• Device Lot Number: 50132783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1