Conquest
Received Apr 13, 2026 · Event occurred Mar 20, 2026
Report 2020394-2026-00920 · MDR key 24856866
Device
Generic name
Pta Balloon Dilatation Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
CQ7564
Lot number
REKU1506
Product problems
- Burst Container or Vessel
- Deflation Problem
- Unraveled Material
Patient
Not reported
- 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 IS CURRENTLY BEING PERFORMED. THE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDED 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 BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THERE WAS AN ATTEMPT TO BURST THE BALLOON USING THE BARD PRESTO INFLATOR, BUT IT DID NOT AFFECT THE BALLOON; HOWEVER, PART OF THE CATHETER BURST UNDER PRESSURE. BALLOON WAS INTACT. THERE WAS NO REPORTED PATIENT INJURY.