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

Model Number U41501H12RX

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 03/03/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure of a target lesion below the knee via an ipsilateral antegrade approach, there was strong resistance felt and the device was allegedly unable to be removed after inflation.The balloon and the guidewire were removed together as one unit.It was further reported that the guidewire was allegedly found detached and the detached segment was in the guidewire lumen.There was no reported patient injury.

Manufacturer Narrative

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.Expiry date (10/2023).

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 10/2023), h11:section a through f - the information provided by bd 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 bd.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure of a target legion below the knee via an ipsilateral antegrade approach, there was strong resistance felt and the device was allegedly unable to be removed after inflation.The balloon and the guidewire were removed together as one unit.There was no reported patient injury.

Manufacturer Narrative

H10: 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 pta dilatation catheter loaded with partial unknown guide wire was returned for evaluation.The guidewire was removed, and dry blood was noted throughout the device.No other anomalies were noted during the visual evaluation.On the functional testing, the guidewire lumen was flushed, and an in-house guide wire was able to insert and remove without any issue.No other functional testing was performed.Therefore, the investigation was confirmed the reported difficulty to remove and device-device incompatibility as the unknown partial guide wire noted to be stuck and loaded with the returned catheter for evaluation.A definitive root cause for the difficult to remove and device-device incompatibility 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.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during an angioplasty procedure of a target legion below the knee via an ipsilateral antegrade approach, there was strong resistance felt and the device was allegedly unable to be removed after inflation.The balloon and the 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 AZ 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: 13963822
• MDR Text Key: 288274773
• Report Number: 2020394-2022-00240
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741055997
• UDI-Public: (01)00801741055997
• 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,Followup,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U41501H12RX
• Device Catalogue Number: U41501H12RX
• Device Lot Number: CMEY0401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• 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