Armada¿
Received Jul 6, 2026 · Event occurred Jun 9, 2026
Report 2024168-2026-02626 · MDR key 25721626
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Abbott Vascular Inc.Model number
B1050-040Catalog number
B1050-040
Lot number
41118G1
Product problems
- Deflation Problem
- Leak/Splash
- Improper or Incorrect Procedure or Method
Patient
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. H6 MEDICAL DEVICE PROBLEM CODE: 2017 - USE AFTER DAMAGE.
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY. DURING PREPARATION OF THE 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) BALLOON THE HUB WAS NOTED TO BE LEAKING WHERE THE INFLATION DEVICE CONNECTS. ALTHOUGH THE LEAK WAS NOTED THE BDC WAS STILL USED IN THE PROCEDURE AND DURING USE THE BALLOON WOULD NOT DEFLATE COMPLETELY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.