inforMED

NEURO PACK

Received Feb 23, 2018 · Event occurred Feb 8, 2018

Report MW5075521 · MDR key 7295987

Device

Generic name

Radiology Diagnostic Kit

Manufacturer

Unk

Catalog number

DYNJ49357A

Lot number

17TB9215

Product problems

  • Device Contamination with Chemical or Other Material

Patient

75 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PT WAS IN INTERVENTIONAL RADIOLOGY (IR) FOR A STROKE THROMBECTOMY. DURING THE FINAL PASS OF THE DEVICE, WHEN THE MD PULLED THE STENT RETRIEVER OUT, THE TEAM NOTICED A "BLUE" ITEM WITHIN THE BASKET OF THE DEVICE. THIS "BLUE" ITEM WAS NOT NOTICED ON ANY PRIOR USES OF THE DEVICE. THE DEVICE AND OTHER CATHETERS ON THE TABLE WERE COLLECTED AND PLACED INTO A BIOHAZARD BAG. THE ITEM APPEARS TO BE BLUE LINT FROM THE TOWELS IN THE KIT. MEDLINE, US.