CONQUEST 40
Received Jul 2, 2026 · Event occurred Jun 12, 2026
Report 2020394-2026-01695 · MDR key 25690495
Device
Generic name
Pta Balloon Dilatation Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
CQF75104
Lot number
REKP1011
Product problems
- Material Rupture
Patient
NA · 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 A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.