ARMADA¿
Received Jul 8, 2026 · Event occurred Jun 19, 2026
Report 2024168-2026-02675 · MDR key 25750978
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Abbott Vascular Inc.Model number
1014258-080Catalog number
1014258-080
Lot number
5031841
Product problems
- Deflation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSED, MILDLY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY THAT IS 60% STENOSED. THE BALLOON OF THE 6.0X80MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE TO NOMINAL PRESSURE. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON, WITH TIME ALLOWED BETWEEN EACH ATTEMPT TO ENSURE ADEQUATE OPPORTUNITY FOR DEFLATION; HOWEVER, THE BALLOON COMPLETELY FAILED TO DEFLATE WHEN USING EITHER THE INFLATION DEVICE OR A SYRINGE. THE BALLOON WAS THEN CAREFULLY WITHDRAWN, AND IT GRADUALLY BEGAN TO DEFLATE DURING REMOVAL. AN UNSPECIFIED BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.