PRESSUREWIRE¿

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED A PRESSUREWIRE X, WIRELESS DEVICE WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. WHILE REMOVING THE DEVICE FROM COIL HOOP, THE DEVICE WAS NOTED TO BE BROKEN. THE DISTAL PART OF THE WIRE IS DESCRIBED AS "RIPPED OFF" BUT NOT BROKEN INTO TWO SEPARATE PIECES. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PRESSUREWIRE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Description of Event or Problem

SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, RETURN DEVICE ANALYSIS REVEALED THE PRESSUREWIRE X, WIRELESS DEVICE WAS NOTED TO BE SEPARATED AT THE PROXIMAL TUBE AND SEPARATION AT THE MICROCABLES. THE ACCOUNT CONFIRMED THE DEVICE WAS DIFFICULT TO REMOVE FROM THE COIL DISPENSER. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED BREAK WAS NOT CONFIRMED; HOWEVER, MATERIAL SEPARATION WAS CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE WAS UNABLE TO BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED PRESSUREWIRE. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED ONE RELATED COMPLAINT ASSESSMENT CAPA. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED TWO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. ALTHOUGH THE REPORTED DIFFICULTY REMOVING FROM THE DISPENSER COIL WAS UNABLE TO BE CONFIRMED, A POTENTIAL PRODUCT QUALITY ISSUE HAS BEEN IDENTIFIED RELATED TO DIFFICULTY REMOVING THE PRESSUREWIRE FROM THE DISPENSER COIL. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.