AVEIR¿ RETRIEVAL SYSTEM CATHETER
Received Aug 15, 2023
Report 2017865-2023-38044 · MDR key 17552297
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LSCR111Product problems
- Break
- Break
Patient
Unknown
- Low Blood Pressure/ Hypotension
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Low Blood Pressure/ Hypotension
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
VOLUNTARY EVENT REPORT WAS RECEIVED. MEDWATCH: MW5119385 H6 HEALTH EFFECT - CLINICAL CODE: APPROPRIATE TERM/CODE NOT AVAILABLE WAS USED FOR INJURY TO THE TRICUSPID VALVE.
Description of Event or Problem
USER FACILITY MEDWATCH RECEIVED THAT STATES A PATIENT PRESENTED FOR A LEADLESS PACEMAKER RETRIEVAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THE PHYSICIAN ATTEMPTED TO USE THE AVEIR RETRIEVAL CATHETER IN COMBINATION WITH ANOTHER UNKNOWN IMPLANT TOOL TO RETRIEVE THE DEVICE. AFTER THE DEVICE WAS ATTACHED, IT WAS NOTED THE PATIENT'S TRICUSPID VALVE AND THE CATHETER WERE DAMAGED. THIS RESULTED IN A DROP IN BLOOD PRESSURE. PHARMACEUTICAL INTERVENTION WAS PERFORMED ALONG WITH THE IMPLANT OF A TEMPORARY PACEMAKER. NO ADDITIONAL INFORMATION WAS AVAILABLE.