SHUNT PAK, 11.5FR DOUBLE-VALVE

Additional Manufacturer Narrative

PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0203 PATIENT PROBLEM CODE: F1905.

Description of Event or Problem

IT WAS REPORTED THAT A DENVER SHUNT WAS IMPLANTED, BUT IT DID NOT WORK AND THE ASCITES WAS NOT DRAINING. WHEN THE WATER WAS TESTED AFTER REMOVAL, IT WAS FOUND TO BE OPEN. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON 04/23/2024: PLEASE REACH OUT AND REQUEST TO VERIFY THE FOLLOWING: - WAS THE CATHETER OCCLUDED? A: I HAVEN'T. - WAS THE PUMP CHAMBER OCCLUDED? A: I HAVEN'T. - HOW WAS THE ISSUE RESOLVED? A: REMOVAL RE-PLACEMENT. - WHAT WAS THE IMPACT TO THE PATIENT? A: I HAD TWO SURGERIES. - IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? A: NONE. - WHEN WAS THE SHUNT PLACED? A: (B)(6) (FRIDAY) MORNING. - DID THE SHUNT REQUIRE REPLACEMENT DUE TO THIS EVENT? A: YES. - WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? A: UNKNOWN.

Additional Manufacturer Narrative

(B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE WATER TEST WAS REPEATED, AND PUMPING THE SHUNT ACTIVATED FLUID FLOW APPROPRIATELY. ADDITIONALLY, THERE WAS NO OCCLUSION DETECTED IN FENESTRATION; THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT A DENVER SHUNT WAS IMPLANTED, BUT IT DID NOT WORK AND THE ASCITES WAS NOT DRAINING. WHEN THE WATER WAS TESTED AFTER REMOVAL, IT WAS FOUND TO BE OPEN. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON 04/23/2024: PLEASE REACH OUT AND REQUEST TO VERIFY THE FOLLOWING: WAS THE CATHETER OCCLUDED? I HAVEN'T. WAS THE PUMP CHAMBER OCCLUDED? I HAVEN'T. HOW WAS THE ISSUE RESOLVED? REMOVAL RE-PLACEMENT. WHAT WAS THE IMPACT TO THE PATIENT? I HAD TWO SURGERIES. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NONE. WHEN WAS THE SHUNT PLACED? (B)(6) (FRIDAY) MORNING. DID THE SHUNT REQUIRE REPLACEMENT DUE TO THIS EVENT? YES. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? UNKNOWN. LOT NUMBER ASSOCIATED WITH REPORTED ISSUE UNKNOWN.