Description of Event or Problem · 0
AVAILABLE INFORMATION AT TIME OF REPORTING REASONABLY SUGGESTS THAT THERE ARE FOUR (4) POTENTIAL PATIENTS DIRECTLY IMPACTED BY ONE SUSPECTED MEDICAL DEVICE. PATIENTS UNDERWENT PROCEDURES INVOLVING THE SAME INDIVIDUAL SUSPECTED MEDICAL DEVICE BETWEEN (B)(6) 2024. BELOW IS NARRATIVE FOR PATIENT #1 (PATIENT CORRESPONDING TO THIS FORM'S SECTION A). FOR PATIENTS #2 - #4. PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2024 FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH SUSPECTED MEDICAL DEVICE FOR REMOVAL OF A STENT PREVIOUSLY PLACED IN (B)(6) 2023. PATIENT HAD A PAST MEDICAL HISTORY OF UNTREATED STAGE IV LUNG CANCER, PANCREATIC ADENOCARCINOMA, AND GERO AND WAS ON PALLIATIVE CARES AT AN ASSISTED LIVING FACILITY FOR MULTIPLE MALIGNANCIES. THE PROCEDURE WAS UNABLE TO REPLACE STENTS AFTER 2 HOURS OF ATTEMPTS TO ADVANCE DUODENOSCOPE. PATIENT WAS DISCHARGED THE SAME DAY. PATIENT HAD AN INFORMATIONAL VISIT WITH HOSPICE ON (B)(6) 2024 WITH PLANS TO TRANSITION TO HOME HOSPICE. PATIENT WAS THEN ADMITTED (B)(6) 2024 FOR WORSENING ABDOMINAL PAIN AND UNDERWENT LNTERVENTIONAL RADIOLOGY (IR) CHOLANGIOGRAPHY AND PERMANENT STENTING OF A MALIGNANT STRICTURE OF THE COMMON BILE DUCT ON (B)(6) 2024. PATIENT HAD IMPROVING ABDOMINAL PAIN AND WAS DISCHARGED ON (B)(6) 2024. ON (B)(6) 2024, PATIENT WAS ADMITTED FOR ACUTE METABOLIC ENCEPHALOPATHY AND SEPTIC SHOCK. PATIENT HAD BEEN SET TO ADMIT TO HOSPICE AT ASSISTED LIVING FACILITY ON (B)(6) 2024, BUT PLANS CHANGED DUE TO HER RETURNING TO THE HOSPITAL. BLOOD CULTURE ON ADMISSION WAS POSITIVE FOR CARBEPENAMASE-PRODUCING CARBEPENEM RESISTANT E. COLI (CP-CRE) AND KLEBSIELLA PNEUMONIAE. FAMILY APPROVED NO ESCALATION OF CARES BEYOND IV ANTIBIOTICS AND FLUIDS. PATIENT PASSED AWAY ON (B)(6) 2024. ON (B)(6) 2024, ERCP PROCEDURE INVOLVING SUSPECTED MEDICAL DEVICE WAS IDENTIFIED AS POSSIBLE LINK BETWEEN MULTIPLE CP-CRE INFECTIONS. ON 8/21/2024, SUSPECTED MEDICAL DEVICE WAS EXAMINED BY BORESCOPE DURING FACILITY INVESTIGATION. BORESCOPE REVEALED A SMALL TEAR WITHIN THE INNER SHEATH OF THE DEVICE. AS OF TIME OF THIS REPORT, IT IS UNKNOWN WHEN TEAR APPEARED ON SCOPE, WHAT CAUSED IT, AND WHETHER IT WAS PRESENT FOR ERCP PROCEDURES INVOLVING AFFECTED PATIENTS.