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

Model Number	U4150310RX
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional 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 pta dilatation catheter was returned for evaluation.No anomalies were noted during the visual evaluation.During functional testing, the balloon was inflated with an in-house presto inflation device, and water was noted to be leaking near the hypotube of the catheter.Under microscopic examination, a tear was noted at the rapid exchange port.No other functional testing was performed.The investigation is confirmed for identified leak as the hypto tube of the catheter leaks during the functional testing.The investigation for the identified catheter tear is also confirmed, as during the microscopic observation, a tear was noted on the hypotube of the shaft.The investigation for the reported balloon rupture remains inconclusive, as functional testing couldn¿t be performed fully due to the tear on the hypotube and the balloon couldn¿t be fully inflated to observe the evidence of rupture.A definitive root cause for the reported balloon rupture and identified catheter tear 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: 12/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX
• Common Device Name: 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: 15948418
• Report Number: 2020394-2022-00972
• Device Sequence Number: 6561260
• Product Code: LIT
• UDI-Device Identifier: 00801741056895
• UDI-Public: (01)00801741056895
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: U4150310RX
• Device Catalogue Number: U4150310RX
• Device Lot Number: CMFN0313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown