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

Model Number U42002H20RX

Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure via contralateral femoral artery, the wire was allegedly floated around the loop.It was further reported that the balloon allegedly would not track around the heel.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse rx pta dilatation catheter loaded onto an unknown guidewire.During the visual evaluation multiple bends were noted throughout the catheter, returned 0.14" guidewire was noted to be bent and kinked throughout.Bunching was noted to the inner guidewire lumen near the guidewire exit port along with tearing to the catheter.The core wire was also exposed distal to the guidewire exit port.No anomalies to the inflation luer.No functional testing due to the condition of the returned sample.All the anomalies noted on microscopic observation.Therefore the investigation was confirmed for the reported failure to advance and device-device incompatibility and identified bunching and inner guide wire lumen tear as the guide wire noted to be stuck within the catheter, bunching and inner guide wire lumen was tear were noted on the returned device.A definitive root cause for the reported failure to advance and device-device incompatibility and identified bunching and inner guide wire lumen tear could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 09/2024).

• Brand Name: ULTRAVERSE RX
• 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 N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14487024
• MDR Text Key: 292489794
• Report Number: 2020394-2022-00399
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056666
• UDI-Public: (01)00801741056666
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2022

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 Model Number: U42002H20RX
• Device Catalogue Number: U42002H20RX
• Device Lot Number: CMFX0457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 113 KG