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

Catalog Number U4150410RX

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008); Air/Gas in Device (4062)

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

Event Date 10/10/2023

Event Type  malfunction  

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.No other anomalies were noted.In the functional testing, negative pressure was applied with an in-house presto inflation device and the pta balloon catheter deflated without any issue and upon inflation of the balloon leak could be identified from the rapid exchange port.During microscopic evaluation material split was observed on the rx port.However, the source of leak is determined to be unknown.No further testing was performed.During the microscopic evaluation and functional testing, the evidence of rapid exchange port split on the returned device was noted.Hence the investigation was confirmed for the identified material split in the rapid exchange port.During functional testing it was confirmed that negative pressure can be applied without issue.Therefore, the investigation unconfirmed for the reported air in device issue.During the functional testing the device leak upon inflation could identified.Hence the investigation confirmed the reported inflation issue and identified leak.During functional testing the device leak upon inflation which might be contributed to the reported inflation issue however the source of leak is unknown.Hence, the definitive root cause for the reported inflation, air in device and identified material split and leak could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2025).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 prior to an angioplasty procedure, the device was attempted to remove air with a syringe, and it was reported that the device allegedly did not respond and failed to be inflated.There was no patient contact.

• 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: 18755531
• MDR Text Key: 335967130
• Report Number: 2020394-2024-00247
• Device Sequence Number: 1
• Product Code: LIT
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: U4150410RX
• Device Lot Number: CMGV0318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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