BIOFLO VORTEX
Report
- Report Number
- 1317056-2025-00251
- Event Type
- Death
- Date Received
- September 17, 2025
- Date of Event
- March 5, 2024
- Report Date
- November 20, 2025
- Manufacturer
- ANGIODYNAMICS, INC
- Product Code
- LJT
- PMA / PMN Number
- K190559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).
THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT THROMBOSIS (AND SUBSEQUENT EXPIRATION) CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT (SAE). NO PORT DEVICE WAS RETURNED FOR EVALUATION SINCE THERE WAS NO REPORT OF PORT DEVICE MALFUNCTION, DAMAGE OR PERFORMANCE ISSUE DURING USE. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE INDICATED PACKAGING LOT REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. THERE HAVE BEEN NO PREVIOUSLY REPORTED COMPLAINTS FOR THE INDICATED PACKAGING LOT FOR SIMILAR PATIENT THROMBOSIS ISSUE. LABELING REVIEW: THE DIRECTION FOR USE (DFU) PROVIDED WITH THE PORT DEVICE CONTAINS THE FOLLOWING STATEMENTS: CONTRAINDICATIONS · PRESENCE OF INFECTION, BACTEREMIA, OR SEPTICEMIA. WARNINGS · THE DEVICE IS TO BE IMPLANTED, USED, MAINTAINED AND REMOVED IN ACCORDANCE WITH CURRENT EVIDENCE-BASED GUIDANCE FOR INFECTION PREVENTION FROM AGENCIES/ORGANIZATIONS SUCH AS CENTERS OF DISEASE CONTROL (CDC) OR THE WORLD HEALTH ORGANIZATION. IT IS RECOMMENDED THAT INSTITUTIONAL POLICIES AND PROCEDURES ARE UPDATED PERIODICALLY TO REFLECT CURRENT EVIDENCE-BASED GUIDELINES FOR INFECTION PREVENTION. · CONTAMINATION OF THE DEVICE MAY LED TO INJURY, ILLNESS OR DEATH OF THE PATIENT. PRECAUTIONS · CAREFULLY READ AND FOLLOW ALL INSTRUCTIONS PRIOR TO USE · AFTER IMPLANTATION OR USAGE OF THE PORT, THE SYSTEM SHOULD BE FLUSHED TO CLEAR INFUSATES AND/OR BLOOD COMPONENTS IN ORDER TO MAINTAIN PATENCY. · IF MORE THAN ONE DRUG IS TO BE ADMINISTERED, BETWEEN THE INDIVIDUAL DRUG APPLICATIONS, FLUSH THE SYSTEM WITH 5 TO 10 ML NORMAL SALINE FOR INJECTION TO PREVENT DRUG INTERACTION. POTENTIAL COMPLICATIONS · BACTEREMIA · CATHETER THROMBOSIS · DEATH · INFLAMMATION · INFECTION · THROMBOEMBOLISM · THROMBOPHLEBITIS · TUNNEL INFECTION · VASCULAR THROMBOSIS USE AND MAINTENANCE AFTER IMPLANTATION OR USAGE OF THE PORT, THE SYSTEM SHOULD BE FLUSHED AND LOCKED TO CLEAR INFUSATES AND/OR BLOOD COMPONENTS IN ORDER TO MAINTAIN PATENCY. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT CONTINUES TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).
ON OR ABOUT (B)(6) 2023, DECEDENT (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, WITH AN UNKNOWN PRODUCT NUMBER, AND LOT NUMBER 5771989. THE SMARTPORT WAS IMPLANTED BY DR. (B)(6) M.D., (B)(6). ON OR ABOUT (B)(6) 2024, DECEDENT PRESENTED TO (B)(6) HOSPITAL FOR A PORT EVALUATION. THE PORT STUDY DEMONSTRATED THAT THE DECEDENT HAD A BLOOD CLOT. ON OR ABOUT (B)(6) 2024, DECEDENT UNDERWENT REMOVAL OF THE BLOOD CLOT. THIS PROCEDURE OCCURRED AT (B)(6) HOSPITAL AND WAS PERFORMED BY DR. (B)(6) M.D. DESPITE EXTENSIVE EFFORTS TO SAVE DECEDENT, HE UNFORTUNATELY PASSED AWAY SECONDARY TO A PULMONARY EMBOLISM AND SEPTIC SHOCK CAUSED BY DEFENDANTS' DEFECTIVE SMARTPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2597781 | BIOFLO VORTEX | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | LJT | ANGIODYNAMICS, INC | H787CT80STBDVI0 | 5771989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other| L| R| H| D |