MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035; PTA BALLOON DILATATION CATHETER

Model Number U357544

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

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

Event Date 10/01/2021

Event Type  malfunction  

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 ultraverse035 pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted to be clean and no other specific anomalies were noted.On the functional evaluation, the guidewire lumen was flushed and the water was noted to be leaking from the inflation hub.On further, an in-house presto inflation device was used to inflate balloon but water was noted exiting from the guidewire hub.Balloon was cut and noted a slit to the inner guidewire lumen just proximal to the balloon, marker bands were also noted to be damaged and dislodged.No other functional testing performed.Therefore the investigation for the reported leak was confirmed, as the water was noted to be leaking from the inflation hub.The investigation for the identified inner guidewire lumen slit was also confirmed, as the slit was noted on the inner guidewire lumen of the balloon under the microscopic observation.The investigation for the identified marker band dislodgement was confirmed, as the marker bands were noted to be dislodged under the microscopic observation.A definitive root cause for the reported leak and the identified inner guidewire lumen slit, marker band dislodgement 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: 10/2023).

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly leaked at hub.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035
• 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: 12874581
• MDR Text Key: 281337439
• Report Number: 2020394-2021-01997
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741091957
• UDI-Public: (01)00801741091957
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142261
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U357544
• Device Catalogue Number: U357544
• Device Lot Number: CMEY0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• 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