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

Model Number	U4150530RX
Medical Device Problem Codes	Kinked (1339); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2016
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.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.Investigation summary: the device was not returned, however two electronic photos were provided for review.Based on the photo review, the investigation is confirmed for both the reported kink, as well as for a complete detachment of the catheter shaft.The definitive root cause for the reported kink or identified detached catheter could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.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 that during a treatment for a lesion, the shaft of the pta balloon catheter allegedly kinked.There was no reported patient injury.
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.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.Investigation summary: the device was not returned, however two electronic photos were provided for review.Based on the photo review, the investigation is confirmed for both the reported kink, as well as for a complete detachment of the catheter shaft.The definitive root cause for the reported kink or identified detached catheter could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.The current japan 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.
Event or Problem Description
It was reported that during a treatment for a lesion, the shaft of the pta balloon catheter allegedly kinked.There was no reported patient injury.

• 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: 7038518
• Report Number: 2020394-2017-01573
• Device Sequence Number: 966393
• Product Code: LIT
• UDI-Device Identifier: 00801741058035
• UDI-Public: (01)00801741058035
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: 09/30/2018
• Device Model Number: U4150530RX
• Device Catalogue Number: U4150530RX
• Device Lot Number: 50130038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1