ACCUSTICK? II
Received Jul 10, 2026 · Event occurred Jun 12, 2026
Report 2124215-2026-37172 · MDR key 25786453
Device
Generic name
Introducer, Catheter
Manufacturer
Boston Scientific CorporationModel number
M001207040Catalog number
M001207040
Lot number
0038946612
Product problems
- Nonstandard Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FURTHER DETAILED EVENT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE RADIOPAQUE TIP CAME OFF. AN ACCUSTICK II W/O .038 WAS SELECTED FOR USE DURING THE PROCEDURE. DURING USE, THE RADIOPAQUE TIP DETACHED FROM THE SHEATH AND SEPARATED WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER ACCUSTICK II W/O .038 DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT, AND THE PATIENT FULLY RECOVERED.