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

Model Number U41502H15RX

Device Problems Inflation Problem (1310); Leak/Splash (1354); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 03/03/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure of a highly calcified target lesion in the anterior tibial artery via an ipsilateral antegrade approach, the pta balloon was allegedly unable to cross the lesion.It was further reported that the shaft of the catheter allegedly bent and contrast leaked from the catheter lumen when the physician pushed and tried to make the catheter cross the lesion.Reportedly, the failure to inflate was found outside the patient.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.(expiration date: 10/2024).

Manufacturer Narrative

H10: 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 was received for evaluation.During visual evaluation, multiple kinks throughout the catheter shaft and bunching of the balloon were observed.The sample was inadvertently severed into two segments and thus functional testing couldn't be performed.Therefore, the investigation is confirmed for the reported material deformation as multiple kinks throughout the catheter shaft and bunching of the balloon were observed.However, the investigation is inconclusive for the reported inability to cross lesion and leak as functional testing could not be performed.A definitive root cause for the alleged inability to cross lesion, material deformation and leak 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.H10: (expiration date: 10/2024).H11: section a through f ¿ the information provided by bd represents all 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 highly calcified target lesion in the anterior tibial artery via an ipsilateral antegrade approach, the pta balloon was allegedly unable to cross the lesion.It was further reported the shaft of the catheter allegedly bent and contrast leaked from the catheter lumen when the physician pushed and tried to make the catheter cross the lesion.Reportedly, the failure to inflate was found outside the patient.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16653011
• MDR Text Key: 312688443
• Report Number: 2020394-2023-00212
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056628
• UDI-Public: (01)00801741056628
• 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
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U41502H15RX
• Device Catalogue Number: U41502H15RX
• Device Lot Number: CMFY0121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• 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