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

Model Number U415048RX

Device Problems Detachment of Device or Device Component (2907); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

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. This is the only complaint reported to date for this lot number and failure mode. Conclusion: the device and the user's 0. 014" guidewire were returned for evaluation. A visual inspection found the balloon to be attached to the device at both the proximal weld joint, as well as at the distal tip. Therefore, the investigation is unconfirmed for the reported detachment. However, a tear at the rapid exchange port was identified, extending distally into the inflation lumen of the device. Therefore, the investigation is confirmed for a tear in the device. Although the device was returned torn, the investigation is unconfirmed for the reported guidewire incompatibility issue, as the returned guidewire was able to slide proximally and distally in the rapid exchange lumen, and it was able to be removed from the device without issue. The identified tear in the device was found to be consistent with the guidewire being pulled out from the device, at the rapid exchange port. However, it is unknown why the guidewire was manipulated in this manner. Therefore, the definitive root cause for the reported or identified issues could not be determined based upon available information. Labeling review: the current ifu (instructions for use) states: warnings: 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 result in tip or catheter breakage, catheter kink, or balloon separation. Do not exceed the rbp recommended for this device. Balloon rupture may occur if the rbp rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. Precautions: 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. Do not continue to use the balloon catheter if the catheter shaft has been bent or kinked. Potential adverse reactions: additional intervention use of the ultraverse rx pta dilatation catheter: while maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the introducer sheath/guide catheter and withdraw the deflated dilatation catheter over-the-wire through the introducer sheath/guide catheter. Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath/guide catheter. (b)(4).

Event Description

It was reported that during an angioplasty procedure the pta balloon allegedly got stuck on the guidewire and subsequently detached. There was no reported patient injury.

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 the pta balloon allegedly detached. 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: 7161302
• MDR Text Key: 268034259
• Report Number: 2020394-2017-01857
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2018
• Device Model Number: U415048RX
• Device Catalogue Number: U415048RX
• Device Lot Number: 50125180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial