inforMED
MalfunctionEZB

NICORE NITINOL GUIDEWIRE

Received Jun 5, 2026 · Event occurred Mar 19, 2026

Report 1018233-2026-03669 · MDR key 25410445

Device

Generic name

Guidewire

Catalog number

150NSS35

Lot number

NGKR2427

Product problems

  • Device Contamination with Chemical or Other Material

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE THE GUIDEWIRE HAD HAIR AT THE FRONT END.