COYOTE?

Description of Event or Problem

REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE BALLOON CATHETER FAILED TO FULLY EXPAND. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY AND WAS SEVERELY CALCIFIED. A 3.0MM X 220MM X 150CM BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON DID NOT FULLY EXPAND DURING INFLATION. THE DEVICE WAS REPLACED WITH A DIFFERENT DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THE DEVICE WAS RETURNED FOR ANALYSIS. THE OUTER SHAFT, INNER SHAFT, BALLOON, AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION IDENTIFIED NO DAMAGE. MICROSCOPIC EXAMINATION IDENTIFIED A PINHOLE LOCATED 22.9 CM FROM THE TIP. NO OTHER DAMAGE OR ABNORMALITIES WERE OBSERVED UPON INSPECTION OF THE REMAINDER OF THE DEVICE. PRODUCT ANALYSIS CONFIRMED THE PRESENCE OF A PINHOLE IN THE BALLOON. DEVICE HISTORY RECORDS (DHR) REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE MOST PROBABLE CAUSE FOR THIS COMPLAINT WAS ADVERSE EVENT RELATED TO PATIENT CONDITION.