ZEBRA

Additional Manufacturer Narrative

THE RETURNED DEVICE WAS EVALUATED BY ENGINEERING TEAM PERSONNEL, AND THE REPORTED EVENT OF DEVICE SEPARATION WAS CONFIRMED. THE EVALUATION DETERMINED THAT THE FAILURE WAS NOT RELATED TO A DESIGN, MANUFACTURING, PACKAGING, OR LABELING ISSUE. PER THE PHYSICIAN'S ACCOUNT, NO INTRODUCER SHEATH WAS USED. HOWEVER, THE PRODUCT INSTRUCTIONS FOR USE (IFU) DIRECT THE USER TO "PLACE AN APPROPRIATELY SIZED INTRODUCER SHEATH INTO THE PRIMARY ACCESS ARTERY" WHEN PREPARING THE DEVICE FOR USE. FAILURE TO USE AN INTRODUCER SHEATH, AS INSTRUCTED IN THE IFU, MAY HAVE INCREASED THE RISK OF DEVICE WALL DEFORMATION (KINKING) DURING NAVIGATION AND MANIPULATION. ADDITIONALLY, THE IFU WARNS THAT "UNRESTRAINED MOVEMENT OR TORQUING OF THE DEVICE AGAINST RESISTANCE MAY RESULT IN VESSEL OR DEVICE DAMAGE." THERE WERE NO RETAINED FRAGMENTS, NO PATIENT INJURY, AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED FOR THIS EVENT. A NEW ZEBRA CATHETER FROM THE SAME LOT WAS USED, THIS TIME WITH AN INTRODUCER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES.

Description of Event or Problem

ANY REQUIRED FIELDS THAT REMAIN UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. Q'APEL MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. Q'APEL MEDICAL MADE MULTIPLE GOOD-FAITH EFFORTS TO COMMUNICATE WITH THE PHYSICIAN TO GATHER MORE INFORMATION REGARDING THE EVENT AND THE PHYSICIAN PERFORMING CASE CONFIRMED THE INFORMATION STATED BELOW. PATIENT DETAILS-NOT PROVIDED, PATIENT AGE: NOT PROVIDED, PATIENT SEX: NOT PROVIDED, MEDICAL CONSIDERATIONS: SCARRED GROIN. PROCEDURE DETAILS: NO SHEATH WAS USED INITIALLY A 6FR VASCULAR DILATOR FOLLOWED BY A 7FR PRE-DILATOR WAS USED AFTER NEEDLE PUNCTURE, MICRO PUNCTURE, AND 0.035" WIRE INSERTION A Q'APEL DILATOR WAS USED WITH A 7FR ZEBRA CATHETER DUE TO THE ABSENCE OF A SHEATH, THE CATHETER WAS INSERTED MANUALLY, INCH BY INCH SOME BACK PRESSURE WAS NOTED DURING INSERTION A DIAGNOSTIC CATHETER WAS INSERTED INTO THE ZEBRA AFTER DILATOR REMOVAL OVER THE WIRE. ISSUE ENCOUNTERED: UNDER FLUOROSCOPY, THE DIAGNOSTIC CATHETER DID NOT MOVE WITH THE ZEBRA AS EXPECTED AFTER APPROXIMATELY TWO MINUTES, ACTIVE BLEEDING ("PINHOLE") FROM THE SIDE OF THE CATHETER WAS OBSERVED AT THE GROIN SITE. UPON ATTEMPTING DEVICE REMOVAL, THE ZEBRA CATHETER SEPARATED, LEAVING A SEGMENT INSIDE THE PATIENT. A 0.035" GUIDEWIRE WAS USED TO SUCCESSFULLY RETRIEVE THE REMAINING CATHETER SEGMENT NO RETAINED FRAGMENTS, NO PATIENT INJURY, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. RESOLUTION: A NEW ZEBRA CATHETER (SAME LOT) WAS USED A SHEATH WAS INSERTED THIS TIME, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED TOTAL PROCEDURE DELAY: 5 MINUTES.