FLEX-CATCH 4 WIRE NITINOL BASKET
Received Jan 2, 2026 · Event occurred Dec 10, 2024
Report 3011050570-2026-00004 · MDR key 23943994
Device
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSE NOT ESTABLISHED. OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE WIRE BASKET WAS FOUND TO BE BROKEN AT THE BASE. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THIS EVENT IS CAUSED BY A COMPONENT FAILURE OF THE SHEATH AND BASKET. THE CAUSE OF FAILURE COULD NOT BE DETERMINED. ALTHOUGH THE ROOT CAUSE COULD NOT BE IDENTIFIED, IT WAS CONFIRMED THAT THE SHEATH AND BASKET WERE FRACTURED AT THE BASE. THIS SUGGESTS THAT PULLING OR PUSHING THE DEVICE MAY HAVE CAUSED BUCKLING OF THE SHEATH ALONG WITH THE BASKET. IT IS PRESUMED THAT THIS BUCKLING ALSO RENDERED THE WIRE USED TO OPERATE THE BASKET INOPERABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.