GLADIATOR? ELITE
Received Jul 5, 2026 · Event occurred Jun 10, 2026
Report 2124215-2026-35899 · MDR key 25712918
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939207060470Catalog number
H74939207060470
Lot number
0035505167
Product problems
- Material Rupture
Patient
69 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE: (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE PRODUCT STATUS AND ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Description of Event or Problem
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A 6.0 X 40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR DILATATION. UPON REACHING THE LESION SITE AND DURING INFLATION, THE BALLOON RUPTURED AT 15 ATMOSPHERES OF PRESSURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE.