TORNADO PLATINUM EMBOLIZATION COIL
Report
- Report Number
- 1820334-2015-00070
- Event Type
- Injury
- Date Received
- February 11, 2015
- Report Date
- January 16, 2015
- Manufacturer
- COOK INC
- Product Code
- KRD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. MORE INFO WILL BE PROVIDED UPON CONCLUSION.
(B)(4). EVENT EVALUATION: DURING THE INVESTIGATION A REVIEW OF COMPLAINT HISTORY, DOCUMENTATION, QUALITY CONTROL, AND TRENDS WAS CONDUCTED. INFORMATION WAS PROVIDED THAT THE PRODUCT WILL NOT BE RETURNED FOR INVESTIGATION. EMBOLIZATION COILS ARE INSPECTED BY A QUALITY CONTROL INSTRUCTION. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED PER SPECIFICATIONS. COILS WERE SENT FROM INVENTORY FOR THIRD PARTY TESTING; WHICH DETERMINED THE CULTURES WERE (B)(6) TO DATE. COOK INC.'S STERILIZATION CYCLES/CHAMBERS ARE VALIDATED. BIOBURDEN TESTING IS PERFORMED AT SCHEDULED INTERVALS TO EVALUATE BIOBURDEN ON PRODUCT POST STERILIZATION. ALL BIOBURDEN TESTING ON PRODUCTS MANUFACTURED IN THE EMBOLIZATION COILS DEPARTMENT IN 2014 WAS WELL UNDER COOK'S ALERT AND ACTION LIMITS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ALTHOUGH THE COMPLAINT FACILITIES THIRD PARTY TESTING OF COOK COILS SHOWED (B)(6) RESULTS, THE COMPLAINT SHALL BE CONFIRMED BASED ON CUSTOMER STATEMENT. WE HAVE NOTIFIED APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.
THE INSTITUTION HAS REPORTED TWO CASES WHERE OERSKOVIA BACTERIUM DEVELOPED A FEW WEEKS AFTER A SPLENIC ARTERY EMBOLIZATION PROCEDURE. THE PROCEDURES WERE PERFORMED BY TWO SEPARATE PHYSICIANS, AND THE ONLY COMMON THREAD CURRENTLY IDENTIFIED IS THE EMBOLIZATION COILS USED. THE INSTITUTION DOES NOT TRACK ANY OTHER PRODUCTS THAT MAY HAVE BEEN USED (CATHETERS, WIRE GUIDES, SHEATHS, CLOSURE DEVICES, ETC) SPECIFIC TO THE PTS. THE FIRST PT, WHO WAS IMMUNOCOMPROMISED, UNDERWENT A SPLENIC EMBOLIZATION DURING THE FIRST WEEK OF DECEMBER. A TOTAL OF FIVE COILS WERE USED. A FEW WEEKS AFTER COIL PLACEMENT, THE PT DEVELOPED OERSKOVIA BACTERIUM. THE PT IS ON HIGH POWERED ANTIBIOTICS AND IS DOING WELL (MDR# 1820334-2015-00070). THE SECOND PT, ALSO IMMUNOCOMPROMISED, UNDER WENT SPLENIC ARTERY EMBOLIZATION ON (B)(6) 2014. AGAIN, EMBOLIZATION COILS WERE USED, BUT OTHER PRODUCTS WERE NOT ABLE TO BE TRACKED. THE PT WAS GIVEN HIGH POWER ANTIBIOTICS AND IS DOING WELL (MDR# 1820334-2015-00071) THE PHYSICIAN INDICATED THAT THEIR INFECTIOUS DISEASE DEPARTMENT IS LOOKING INTO THE MATTER.
THE INSTITUTION HAS REPORTED TWO CASES WHERE OERSKOVIA BACTERIUM DEVELOPED A FEW WEEKS AFTER A SPLENIC ARTERY EMBOLIZATION PROCEDURE. THE PROCEDURES WERE PERFORMED BY TWO SEPARATE PHYSICIANS, AND THE ONLY COMMON THREAD CURRENTLY IDENTIFIED IS THE EMBOLIZATION COILS USED. THE INSTITUTION DOES NOT TRACK ANY OTHER PRODUCTS THAT MAY HAVE BEEN USED (CATHETERS, WIRE GUIDES, SHEATHS, CLOSURE DEVICES, ETC.) SPECIFIC TO THE PATIENTS. THE FIRST PATIENT, WHO WAS IMMUNOCOMPROMISED, UNDERWENT A SPLENIC EMBOLIZATION DURING THE FIRST WEEK OF DECEMBER. A TOTAL OF (B)(6) COILS WERE USED. A FEW WEEKS AFTER COIL PLACEMENT, THE PATIENT DEVELOPED OERSKOVIA BACTERIUM. THE PATIENT IS ON HIGH POWER ANTIBIOTICS AND IS DOING WELL (1820334-2015-00070). THE SECOND PATIENT, ALSO IMMUNOCOMPROMISED, UNDERWENT SPLENIC ARTERY EMBOLIZATION ON (B)(6) 2014. AGAIN, EMBOLIZATION COILS WERE USED, BUT OTHER PRODUCTS WERE NOT ABLE TO BE TRACKED. THE PATIENT WAS GIVEN HIGH POWER ANTIBIOTICS AND IS DOING WELL (1820334-2015-00071). THE PHYSICIAN INDICATED THAT THEIR INFECTIOUS DISEASE DEPARTMENT IS LOOKING INTO THIS MATTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100093 | TORNADO PLATINUM EMBOLIZATION COIL | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | COOK INC | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |