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

Model Number U4150515RX

Device Problems Difficult to Remove (1528); Material Separation (1562); Device-Device Incompatibility (2919)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

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: one ultraverse rx device was received for evaluation.The device guidewire lumen was attempted to be flushed but was unsuccessful.An inhouse guidewire was attempted to be inserted but was unable to be inserted.The device was cut and under microscopic examination an unknown object was noted within the guidewire lumen.The material was noted to likely be the inner most layer of the inner lumen separating from the catheter.Therefore, the investigation is confirmed for the reported guidewire removal issue, as a device guidewire was unable to be fully inserted through the device.The investigation is also confirmed for the identified material separation, as the inner lumen was noted to be separated and blocking the guidewire lumen.The definitive root cause of the identified material separation and guidewire removal issue could not be determined based upon the available 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: 10/2023).

Event Description

It was reported that during an angioplasty procedure, the guidewire allegedly got stuck with the recanalization catheter.It was further reported that the catheter and guidewire were removed together as one unit.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12981971
• MDR Text Key: 282104463
• Report Number: 2020394-2021-02062
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741057946
• UDI-Public: (01)00801741057946
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U4150515RX
• Device Catalogue Number: U4150515RX
• Device Lot Number: CMEY0317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2020
• 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