DORADO

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: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DIFFICULT TO OPEN OR REMOVE PACKAGING MATERIAL AND BREAK 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. D2B (DQY; LIT). H11: 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.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT WAS SCHEDULED TO UNDERGO AN ANGIOPLASTY PROCEDURE USING A DORADO PTA BALLOON. DURING PRE PROCEDURAL DEVICE PREPARATION, THE BALLOON PROTECTIVE SLEEVE WAS DIFFICULT TO REMOVE. A FRACTURE WAS OBSERVED IN THE CATHETER SHAFT AT THE JUNCTION WITH THE PROXIMAL PORTION OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS ABNORMAL DIFFICULTY IN REMOVING THE BALLOON PROTECTION SLEEVE. THE BALLOON MATERIAL WAS RUPTURED, AND A FRACTURE WAS IDENTIFIED IN THE CATHETER SHAFT AT THE JUNCTION WITH THE PROXIMAL PORTION OF THE BALLOON. THERE WAS NO PATIENT CONTACT.