MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014; PTA BALLOON DILATATION CATHETER

Model Number	U4150330
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon was allegedly unable to cross lesion.There was no reported patient injury.
Additional 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 ultraverse 014 pta dilatation catheter was returned for evaluation.Balloon twisting was able to be observed on the retuned device.No other specific anomalies noted during the visual evaluation.On the functional evaluation, the guide wire lumen was flushed and an in-house guide wire was able to insert and remove through the catheter without any issue.Further, the balloon was inflated with an in-house presto inflation device and water was noted to be leaking from the balloon.Under microscopic observation it was noted a longitudinal rupture.No further testing was performed.Therefore, the investigation for reported unable to cross lesion remains inconclusive as the condition of use could not be reproduced on the laboratory condition.However, the investigation was confirmed for an identified balloon twist as the twisted balloon was able to observe during the visual evaluation of the returned sample.The investigation was also confirmed for identified balloon rupture as a longitudinal balloon rupture was observed under the microscope and water also leaks from the balloon during the functional testing.A definitive root cause for the reported unable to cross lesion, identified balloon twist and balloon rupture 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.

• Brand Name: ULTRAVERSE 014
• 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: 14600024
• Report Number: 2020394-2022-00437
• Device Sequence Number: 5077129
• Product Code: LIT
• UDI-Device Identifier: 00801741064463
• UDI-Public: (01)00801741064463
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2022

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: U4150330
• Device Catalogue Number: U4150330
• Device Lot Number: CMDV0159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 56 YR
• Patient Sex: Female