SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN

Description of Event or Problem

IT WAS REPORTED TO THE SALES REP THAT POST-OP OF A LUMBAR DECOMPRESSION PROCEDURE THAT THE PATIENT BECAME ILL AND REQUIRED TWO ADDITIONAL HOSPITAL STAYS. PATIENT TESTED POSITIVE FOR E-COLI AND BREZIEACTERIUM CAESI. PATIENT RECEIVED NO IMPLANTS OTHER THAN THE SURGIFLO. DOCTOR HAS NO IDEA WHAT CAUSED THE SSI. PATIENT SAFETY OFFICER MENTIONED THEY HAD TWO PREVIOUS INSTANCES WITH A SIMILAR COMPETITORS PRODUCT (FLOSEEL). PATIENT DOING FINE.NO DEVICE IS AVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

FOLLOW-UP INFORMATION WAS RECEIVED. THE FOLLOW-UP INFORMATION INCLUDES A SECOND CASE AND AN ADDITIONAL QN IS CREATED (QN (B)(4)). IT IS STATED THAT SURGIFLO WAS LEFT IN THE PATIENT THUS THE USE IS NOT WITHIN INTENDED USE (USE ERROR). IN THE IFU IT IS STATED THAT "GELATIN-BASED HAEMOSTATIC AGENTS MAY SERVE AS A NIDUS FOR INFECTION AND ABSCESS FORMATION AND HAVE BEEN REPORTED TO POTENTIATE BACTERIAL GROWTH." SINCE SEVERAL CASES ARE OBSERVED IN THE HOSPITAL WITH OTHER HEMOSTATS AS WELL (FLOSEAL) IT APPEARS TO BE AN ISSUE AT THE HOSPITAL AND NOT THE HEMOSTATIC DEVICES, HOWEVER IT CANNOT BE COMPLETELY RULED OUT THAT SURGIFLO CONTRIBUTED TO THE EVENT (SINCE GELATIN CAN BE A NIDUS FOR INFECTION). SINCE A SECOND CASE WAS IDENTIFIED IN THE FOLLOW-UP INFORMATION, AN EXTENDED BATCH FILE REVIEW WAS PERFORMED BY A SUBJECT MATTER EXPERT, PRINCIPAL QC SPECIALIST, MICROBIOLOGIST: THE PRINCIPAL QC SPECIALIST, MICROBIOLOGIST, CONCLUDE THAT "IT IS HIGHLY UNLIKELY THAT THE SURGIFLO WITH BATCH NO. 275885 SHOULD HAVE CAUSED THE REPORTED INFECTION BY BREVIBACTERIUM CASEI AND ESCHERICHIA COLI IN THE PATIENT. IT IS CONCLUDED THAT THERE IS NO PRODUCT PROBLEM OR PRODUCT QUALITY ISSUE." IN CONCLUSION, IT IS EVALUATED THAT IT IS HIGHLY UNLIKELY THAT THE CAUSE OF INFECTION RELATES TO SURGIFLO. HOWEVER, IT CANNOT BE RULED OUT THAT SURGIFLO CONTRIBUTED TO THE EVENT (SINCE GELATIN CAN BE A NIDUS FOR INFECTION) THUS THE CASE REMAINS REPORTABLE.

Description of Event or Problem

IT WAS REPORTED TO THE SALES REP THAT POST-OP OF A LUMBAR DECOMPRESSION PROCEDURE THAT THE PATIENT BECAME ILL AND REQUIRED TWO ADDITIONAL HOSPITAL STAYS. PATIENT TESTED POSITIVE FOR E-COLI AND BREZIEACTERIUM CAESI. PATIENT RECEIVED NO IMPLANTS OTHER THAN THE SURGIFLO. DOCTOR HAS NO IDEA WHAT CAUSED THE SSI. PATIENT SAFETY OFFICER MENTIONED THEY HAD TWO PREVIOUS INSTANCES WITH A SIMILAR COMPETITORS PRODUCT (FLOSEEL). PATIENT DOING FINE. NO DEVICE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED: INDICATION SURGIFLO WAS USED? WHICH TYPE OF BLEEDING? LUMBAR MICRODISCECTOMY. MILD OOZING. WAS SURGIFLO LEFT OR REMOVED AFTER HEMOSTASIS WAS ACHIEVED? REMAINED. IS THE CAUSE OF INFECTIONS BEING INVESTIGATED AT THE HOSPITAL SINCE ALSO 2 OTHER SURGERIES RESULTED IN INFECTION (FOR FLOSEAL)? FINDINGS: ON (B)(6)2024 REVISION MICRODISC W/FUSION FLOSEAL & DURASEAL USED. SERRATIA], ON (B)(6)2024 REV MICRODISC, FLOSEAL USED. STAPH AUREUS], ON (B)(6)2024 MICRODISC, SURGIFLO#2994. LOT 275885 E. COLI, BREVIBACTERIUM], ON (B)(6)2024 LUM HEMILAMI- SURGIFLO #2994. LOT 275890. STAPH AUREUS] OR STAFF, AND PT CHARACTERISTICS VARIED. WE'RE ALSO INVESTIGATING A MEDLINE SURGICAL COTTONOID RECALL. HOW MANY DAYS AFTER SURGERY WAS THE INFECTION DISCOVERED? INFECTIONS SYMPTOMS AND ONSET VARIED. AVG 3-4 WEEKS POSTOP. DOES THE PATIENT HAVE A HISTORY OF INFECTIONS? NONE NOTED IN HISTORY. CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED?: O NO. NOT TO THAT EXTENT. THE 4 SSI EVENTS INVOLVED MALE PATIENTS. NO SIGNIFICANT COMORBIDITIES. BMI RANGES: 26 TO 32. ALL WERE READMITTED AND REQUIRED SURGICAL I&D, DRAINS, PICC ABX. WHAT IS THE SURGEON'S OPINION AS TO THE RELATIONSHIP OF THE PRODUCT TO THE SYMPTOMS? NO COMMENTS RELATING HEMOSTATIC CONTRIBUTING TO SSIS. WAS MEDICAL INTERVENTION INDICATED TO TREAT THE SYMPTOMS? IF SO, WHAT WAS THE MEDICAL INTERVENTION REQUIRED? WHAT IS THE CURRENT CONDITION OF THE PATIENT? SEE ABOVE. ONE PT IN PARTICULAR FROM (B)(6) 2024 HAS BEEN VERY ILL WITH REPEATED READMISSIONS ((B)(6) 1940. (B)(4). THE OTHER 3 PTS APPEAR TO BE RESOLVING.