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

Model Number	U4150230RX
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
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 ultraverse rx pta dilatation catheter was returned for evaluation.No kinks noted to the catheter shaft; no other anomalies noted on the inflation luer.Under microscopic observation it was observed that the inner guide wire lumen was kinked at the proximal end of the balloon.No functional testing was performed due to the condition of the device.Therefore, the investigation for the reported unable to cross lesion remains inconclusive as the conditions of use could not be replicated in laboratory conditions.However, the investigation was confirmed for material deformation as the inner guide wire lumen was noted to be kinked and was observed during the microscopic observation.A definitive root cause for the reported unable to cross lesion and kink 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 or Problem Description
It was reported that during an angioplasty procedure of a highly calcified target lesion below the knee, the pta balloon was allegedly unable to cross the lesion.It was further reported that the catheter shaft was allegedly kinked.The procedure was completed using another device.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 rx pta dilatation catheter was returned for evaluation.No kinks noted to the catheter shaft; no other anomalies noted on the inflation luer.Under microscopic observation it was observed that the inner guide wire lumen was kinked at the proximal end of the balloon.No functional testing was performed due to the condition of the device.Therefore, the investigation for the reported unable to cross lesion remains inconclusive as the conditions of use could not be replicated in laboratory conditions.However, the investigation was confirmed for material deformation as the inner guide wire lumen was noted to be kinked and was observed during the microscopic observation.A definitive root cause for the reported unable to cross lesion and kink 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 or Problem Description
It was reported that during an angioplasty procedure of a highly calcified target lesion below the knee, the pta balloon was allegedly unable to cross the lesion.It was further reported that the catheter shaft was allegedly kinked.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13511945
• Report Number: 2020394-2022-00094
• Device Sequence Number: 17470946
• Product Code: LIT
• UDI-Device Identifier: 00801741056383
• UDI-Public: (01)00801741056383
• 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): 02/11/2022

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: U4150230RX
• Device Catalogue Number: U4150230RX
• Device Lot Number: CMEY0594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/11/2022
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 40 KG