N
Patient 1
THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT THAT THE GUIDEWIRE BECAME STUCK IN THE INTRODUCER NEEDLE WAS CONFIRMED AND THE DAMAGE APPEARED TO BE RELATED TO USE OF THE DEVICE. ONE 0.038? GUIDEWIRE WAS RECEIVED WITHIN AN 18G INTRODUCER NEEDLE. THE DISTAL TIP OF THE GUIDEWIRE WAS LODGED IN THE NEEDLE. THE GUIDEWIRE WAS NOT EXTENDING FROM THE DISTAL TIP OF THE INTRODUCER NEEDLE. A MICROSCOPIC EXAMINATION OF THE 18G INTRODUCER NEEDLE REVEALED THAT THE INNER EDGE OF THE OPENING AT THE NEEDLE BEVEL WAS DEFORMED. BLOOD RESIDUE WAS VISIBLE WITHIN THE NEEDLE. IT WAS NOTED THAT THE CORE WIRE BROKE AT THE DISTAL WELD TIP, WHICH ALLOWED THE COIL WIRE TO STRETCH OVER THE CORE WIRE. THE GUIDEWIRE WAS FORCEFULLY PULLED FROM THE INTRODUCER NEEDLE. BIOLOGICAL MATERIAL WAS FOUND ON THE SECTION OF COIL WIRE THAT WAS WITHIN THE INTRODUCER NEEDLE. THE DAMAGE AT THE NEEDLE BEVEL AND THE PRESENCE OF BIOLOGICAL RESIDUE LODGED BETWEEN THE GUIDEWIRE AND NEEDLE INDICATE THAT THE GUIDEWIRE WAS RETRACTED WITHIN THE INTRODUCER NEEDLE. THE OUTSIDE DIAMETER (OD) OF THE GUIDEWIRE WAS FOUND TO BE WITHIN SPECIFICATION. THE PRODUCT IFU CAUTIONS, ?DO NOT PULL BACK GUIDEWIRE OVER NEEDLE BEVEL AS THIS MAY SEVER THE END OF THE GUIDEWIRE. THE INTRODUCER NEEDLE MUST BE REMOVED FIRST. ALSO, IF UNUSUAL RESISTANCE IS MET DURING MANIPULATION OF THE GUIDEWIRE, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. WITHDRAW NEEDLE AND GUIDEWIRE IF CAUSE OF RESISTANCE CANNOT BE DETERMINED.? A LOT HISTORY REVIEW (LHR) OF RECR1630 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.