Ultraverse RX
Received Jul 3, 2026 · Event occurred Jun 15, 2026
Report 2020394-2026-01707 · MDR key 25701250
Device
Generic name
Pta Balloon Dilatation Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
U415054RX
Lot number
CMKR0203
Product problems
- Material Rupture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) ARE ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ULTRAVERSE RX PTA BALLOON. DURING THE PROCEDURE, THE BALLOON REPORTEDLY RUPTURED ON THE FIRST ATTEMPT. EVEN AFTER TRYING THE SAME SIZE WITH DIFFERENT LENGTHS, THE HEALTHCARE PROFESSIONALS WERE UNABLE TO DILATE THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.