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

Catalog Number U4150310RX

Device Problems Kinked (1339); Retraction Problem (1536); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or 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 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 Description

It was reported that during an angioplasty procedure of a heavily calcified lesion in the sfa, allegedly there was difficulty removing the pta balloon catheter through the sheath after the second inflation.Upon removal from the patient, the pta balloon catheter was found to be kinked.There was no reported patient injury.

Manufacturer Narrative

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.Visual/microscopic inspection: the catheter was kinked throughout the balloon portion of the device.Balloon is noted to be twisted.No other anomalies were observed.Functional/performance evaluation: the patency of the guidewire lumen was tested using in-house 0.014¿ guidewire.The guidewire was unable to be fully inserted due to dried blood and poor sample condition.Further functional testing could be performed due to poor sample condition.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 device was returned.Based on the condition of the returned device, the investigation is confirmed for a kinked catheter and twisted balloon.The investigation is inconclusive for sheath related retraction issues, due to the poor sample condition.It is likely the reported retraction issues contributed to the kinked catheter and twisted balloon.However, the definitive root cause could not be determined based on the 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 Description

It was reported that during an angioplasty procedure of a heavily calcified lesion in the sfa, allegedly there was difficulty removing the pta balloon catheter through the sheath after the second inflation.Upon removal from the patient, the pta balloon catheter was found to be kinked.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA BALLOON 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: 6366860
• MDR Text Key: 68603133
• Report Number: 2020394-2017-00129
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056895
• UDI-Public: (01)00801741056895(17)180310(10)50120984
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

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: 03/10/2018
• Device Catalogue Number: U4150310RX
• Device Lot Number: 50120984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 02/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• 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
• Patient Age: 80 YR