SURGIFLO¿ HEMOSTATIC MATRIX
Received May 6, 2025
Report 3008478369-2025-00014 · MDR key 21966152
Device
Generic name
Agent, Absorbable Hemostatic, Collagen Based
Manufacturer
Ferrosan Medical Devices A/sModel number
2991Product problems
- Off-Label Use
- Off-Label Use
Patient
NA · Unknown
- Hematoma
- Hematoma
Narrative
Additional Manufacturer Narrative
NO LOT NUMBER IS AVAILABLE.
Description of Event or Problem
IT WAS REPORTED BY THE SURGEON THAT THEY ARE AN INTERVENTIONAL RADIOLOGIST AND HAVE BEEN USING SURGIFLO TO OCCLUDE BIOPSY TRACTS. THEY HAVE HAD MORE HEMATOMAS THEN THEY WOULD EXPECT AFTER KIDNEY BIOPSIES.
Additional Manufacturer Narrative
NO LOT NUMBER IS AVAILABLE. BASED ON THE SURGEON'S STATEMENT, SURGIFLO DID NOT CAUSE THE HEMATOMAS, THUS IT IS EVALUATED THAT THERE ARE NO CAUSAL RELATIONSHIPS BETWEEN THE HEMATOMAS AND SURGIFLO.
Description of Event or Problem
IT WAS REPORTED BY THE SURGEON THAT THEY ARE AN INTERVENTIONAL RADIOLOGIST AND HAVE BEEN USING SURGIFLO TO OCCLUDE BIOPSY TRACTS. THEY HAVE HAD MORE HEMATOMAS THEN THEY WOULD EXPECT AFTER KIDNEY BIOPSIES. ADDITIONAL INFORMATION WAS RECEIVED STATING: I MAINLY WOULD LIKE TO KNOW IF THIS IS AN ESPECIALLY CONCERNING USE OF YOUR PRODUCT. I SEE NO REASON WHY USING SURGIFLO TO OCCLUDE A BIOPSY TRACT WOULD CAUSE AN INCREASE IN THE RISK OF HEMATOMAS. I'VE ONLY USED IT FOR KIDNEY AND LIVER 18G CORE NEEDLE BIOPSIES. I WOULD BE HAPPY TO DISCUSS THIS ON THE PHONE. 3RD ADDITIONAL INFORMATION REQUEST: · DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? 2. · WHAT IS THE TOTAL NUMBER OF PROCEDURES? 2. · HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). NO. · IF THIS EVENT OCCURRED IN MULTIPLE PROCEDURES, PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH PATIENT EVENT: - PLEASE ELABORATE IF THE USE IS INTENTIONALLY OFF-LABEL (SEAL TRACT)? KNOWN TO BE OFF-LABEL - HOW MUCH SURGIFLO WAS USED IN THE PATIENT? 1-2 ML - WAS SURGIFLO REMOVED OR LEFT IN THE PATIENT? LEFT IN PATIENT - PLEASE PROVIDE PATIENT IDENTIFIERS (INITIALS, AGE ETC.) FOR EACH PATIENT EXPERIENCING HEMATOMA - (PLEASE REFER THE ATTACHED EMAIL FOR PATIENT IDENTIFIERS) - PLEASE ELABORATE WHY THE SURGEON/S THINK THAT THE HEMATOMA IS CAUSED BY SURGIFLO? NOT CAUSED BY, BUT NOT PREVENTED BY. - HOW WAS THE HEMATOMA TREATED IN EACH PATIENT? --(PLEASE REFER THE ATTACHED EMAIL FOR PATIENT IDENTIFIERS)- HAD SUBCAPSULAR HEMATOMA. DISCHARGES SAME DAY. IT WAS DRAINED PERCUTANEOUSLY 3 WEEKS LATER. --(PLEASE REFER THE ATTACHED EMAIL FOR PATIENT IDENTIFIERS)- HAD HEMATOMA INTO RETROPERITONEAL FAT. IT WAS NOT CONTIGUOUS WITH THE KIDNEY. IT MAY HAVE BEEN BLEEDING FROM A RETROPERITONEAL VESSEL.