MalfunctionOWQ
NA
Received Mar 24, 2023 · Event occurred Mar 20, 2023
Report 16609592 · MDR key 16609592
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
RD087031Catalog number
RD087031
Lot number
2181932
Product problems
- Break
- Output Problem
- Sharp Edges
Patient
23360 DA · Female
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
MID 60¿S FEMALE WITH HISTORY OF PERSISTENT ATRIAL FIBRILLATION. PROCEDURE: ABLATION CRYO-ENSITE. STEERABLE CATHETER GETS RE-STERILIZED OUTSIDE THE HOSPITAL AT A COMPANY, STERILMED. WHEN THE RE-STERILIZED CATHETER WAS USED, IT WOULD NOT STEER AND HAD A SHARP ANGLE ON IT. WE REMOVED IT FROM THE CASE THE TIP WAS BROKEN. A BRAND NEW CATHETER WAS OPENED AND USED. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER, NA (PER SITE REPORTER). WILL OBTAIN.