CONQUEST

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING A CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED, AND THE GUIDEWIRE BECAME TWISTED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT. INVESTIGATION SUMMARY: RECEIVED ONE CONQUEST PTA DILATATION CATHETER. UPON VISUAL INSPECTION A CRIMP MARK AND STRETCHING WERE NOTED TO THE CATHETER SHAFT AT THE DISTAL TIP OF THE BALLOON. NO ANOMALIES IDENTIFIED TO THE LUERS, BIFURCATE AND GLUE FILLETS. ON FUNCTIONAL TESTING, NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON WITH AN IN-HOUSE PRESTO INFLATION DEVICE. WITH THE SAME IN-HOUSE PRESTO INFLATION DEVICE, THE BALLOON WAS INFLATED AND MAINTAINED PRESSURE, WITH NO WATER LEAKAGE OBSERVED. IT WAS THEN REINFLATED RBP, AGAIN WITH NO EVIDENCE OF WATER LEAKAGE. NO ADDITIONAL FUNCTIONAL TESTING WAS PERFORMED. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED BALLOON RUPTURE AS THE BALLOON WAS INFLATED AND MAINTAINED PRESSURE, WITH NO WATER LEAKAGE OBSERVED. HOWEVER, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED STRETCHING WERE NOTED TO THE CATHETER SHAFT AT THE DISTAL TIP OF THE BALLOON. A DEFINITIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE AND IDENTIFIED STRETCHING COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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.