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

Catalog Number U415064RX

Device Problems Retraction Problem (1536); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2016

Event Type  malfunction  

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 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 photo shows the sample laying coiled.The sample is used, and the balloon appears to have been previously inflated.No kinks or physical anomalies were noted to the catheter or hub.Upon closer examination of the balloon, no ruptures or signs of retraction issues could be identified.Based on the photo provided, the reported issues could not be confirmed.Conclusion: one photo was provided for review.The investigation is inconclusive for the reported issues as the photo provided could not identify any signs of advancement or retraction issues, and as the device was not returned for full functional evaluation.The definitive root cause for the reported issues could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current (b)(4) 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 Description

It was reported that during a thrombectomy procedure in the iliac artery; post pta balloon inflation the catheter was allegedly difficult to remove due to the interaction with a parachute (filter for downstream thrombectomy) previously placed for the thrombectomy.A guiding catheter was advanced over the iliac bifurcation for better access to the iliac lesion.Although difficulty advancing the pta balloon to the iliac lesion was experienced, successfully angioplasty was achieved.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6677723
• MDR Text Key: 78722696
• Report Number: 2020394-2017-00747
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741058066
• UDI-Public: (01)00801741058066(17)170930(10)50113805
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: U415064RX
• Device Lot Number: 50113805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1