NAMIC

Additional Manufacturer Narrative

UPDATED H6: INVESTIGATION FINDINGS (C). UPDATED H6: INVESTIGATION CONCLUSIONS (D). UPDATED H7: IF REMEDIAL ACTION INITIATED, CHECK TYPE. UPDATED H9: IF ACTION REPORTED TO FDA UNDER 21 USC 360I(G), LIST CORRECTION/REMOVAL REPORTING NUMBER.

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, AFTER FIRST SHOT OF RIGHT CORONARY ARTERY, THE SYRINGE CONNECTION BECAME LOOSE, AND CONTRAST RAN OUT FROM THE CONNECTION. SYRINGE WAS UNSTABLE TO STAY ON MANIFOLD, AND THE SYRINGE WAS CHANGED OUT. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(4) ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

ACCORDING TO THE FACILITY, AFTER FIRST SHOT OF RIGHT CORONARY ARTERY, THE SYRINGE CONNECTION BECAME LOOSE, AND CONTRAST RAN OUT FROM THE CONNECTION. SYRINGE WAS UNSTABLE TO STAY ON MANIFOLD, AND THE SYRINGE WAS CHANGED OUT.