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

Model Number	U35130610
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
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 ultraverse035 pta dilatation catheter has returned for evaluation.No specific anomalies noted on the visual evaluation.On the functional evaluation the balloon catheter was inflated with the in-house presto device, upon inflation water was noted leak from the catheter near the strain relief.Under the microscopic observation a longitudinal tear was noted to the catheter.No further testing performed.Therefor the investigation was confirmed for the reported catheter leak, as the catheter leak during the functional evaluation.The investigation was also confirmed for the identified catheter tear as a longitudinal tear was noted to the catheter under microscopic observation.During the microscopic observation longitudinal tear was noted to the catheter was identified which leads to the reported leak.However, definitive root cause for the reported catheter leak 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: 03/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the shaft on the pta balloon allegedly leaked.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12966369
• Report Number: 2020394-2021-02049
• Device Sequence Number: 11860804
• Product Code: LIT
• UDI-Device Identifier: 00801741093203
• UDI-Public: (01)00801741093203
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

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: U35130610
• Device Catalogue Number: U35130610
• Device Lot Number: CMFR0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/09/2021
• 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 Sex: Unknown