Description of Event or Problem · 0
DURING TERMINATION OF PREGNANCY (TOP) THE DILATOR DILAPAN-S WAS USED FOR CERVICAL DILATION. DURING THE THIRD CERVICAL DILATION PROCEDURE, 4 RODS OF DILAPAN-S WERE INSERTED. NEXT DAY DURING REMOVAL ONLY 3 RODS WERE REMOVED, THE 4TH ROD REMAINED IN SITU, ONE OF THE REMOVED RODS HAD THE MARKER STRING UNRAVELED. THE 4TH ROD WAS NOT ABLE TO BE LOCALIZED; THEREFORE, ECHOGRAPHY WAS PERFORMED TO CONFIRM ITS LOCATION IN THE UTERUS. THE 4TH ROD WAS EXPELLED NATURALLY DURING LABOR PROGRESSION. SUBSEQUENT EXAMINATIONS SHOWED NO ABNORMALITIES. THE MIGRATED DILATOR WAS SMOOTHLY REMOVED; ITS MARKER STRING WAS ALSO UNRAVELED BUT SUCCESSFULLY REMOVED FROM THE PATIENT. NO ACTUAL IMPACT ON THE STATE OF HEALTH REPORTED. THE REASON FOR REPORTING IS A POTENTIAL RISK OF INFECTION IN CASE THE MARKER STRING WAS LEFT IN SITU WHEN THE DILATOR MIGRATED INTO THE UTERUS. THE MOST PROBABLE ROOT CAUSE IS THAT THE KNOT ON THE MARKER STRING WAS UNTIED DURING THE PROCEDURE. IN SUCH CASE THE LOOSE MARKER STRING IN THE VAGINA ALONE WOULD NOT PROBABLY LEAD TO ANY SERIOUS DETERIORATION IN THE STATE OF HEALTH BUT COMBINED WITH THE MIGRATION OF THE DILATOR INTO THE UTERUS, IT BECOMES A POTENTIAL SOURCE OF INFECTION IF LEFT IN PLACE. MIGRATION OF THE DILATOR IS A KNOWN COMPLICATION DESCRIBED IN THE INSTRUCTIONS FOR USE TOGETHER WITH THE IMPORTANCE OF REMOVING ALL FRAGMENTS FROM THE UTERUS IN CASE OF FRAGMENTATION. BATCH RECORD REVIEW CONFIRMED NO NON-CONFORMITIES RELATED TO THE MARKER STRING OR KNOT-TYING PROCESS FOR THE AFFECTED BATCH. BASED ON THE INVESTIGATION, THE MOST PROBABLE SCENARIO IS AN ISOLATED MANUFACTURING DEVIATION (INSUFFICIENT KNOT TIGHTENING) COMBINED WITH A KNOWN CLINICAL COMPLICATION (DILATOR MIGRATION). THIS COMBINATION IS CONSIDERED HIGHLY IMPROBABLE AND DOES NOT INDICATE A SYSTEMIC ISSUE WITHIN THE BATCH. THE RISK OF INSUFFICIENT KNOT TIGHTENING IS ALREADY ADDRESSED IN THE RISK ANALYSIS WITH AN OCCURRENCE CLASSIFIED AS IMPROBABLE (< 1 IN 10,000). HISTORICAL DATA SUPPORT THIS ASSESSMENT: IN THE LAST FIVE YEARS (2020-2024), ONLY ONE COMPLAINT POTENTIALLY RELATED TO AN UNTIED KNOT WAS REPORTED AMONG (B)(4) DISTRIBUTED DILATORS, CORRESPONDING TO A PROBABILITY WELL BELOW THE THRESHOLD. THIS UNIQUE COMBINATION OF TWO INDEPENDENT EVENTS - UNTIED KNOT AND DILATOR MIGRATION - DOES NOT INCREASE THE OVERALL RISK FOR OTHER RODS IN THE BATCH. DILATOR MIGRATION IS A KNOWN COMPLICATION DESCRIBED IN THE INSTRUCTIONS FOR USE, AND THE IMPORTANCE OF REMOVING ALL FRAGMENTS IS EMPHASIZED. THEREFORE, NO ADDITIONAL RISK FOR PATIENT SAFETY IS EXPECTED BEYOND WHAT IS ALREADY MITIGATED IN THE EXISTING RISK MANAGEMENT PROCESS. AN INTERNAL CAPA HAS BEEN INITIATED TO FURTHER REDUCE THE LIKELIHOOD OF INSUFFICIENT KNOT TIGHTENING.