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

Model Number U4150230RX

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 01/14/2022

Event Type  malfunction  

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 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.

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 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
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13511945
• MDR Text Key: 285463365
• Report Number: 2020394-2022-00094
• 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

• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Date Manufacturer Received: 01/14/2022
• 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