SYSTEM 9735542 15W VISUALASE
Report
- Report Number
- 1723170-2016-01276
- Event Type
- Death
- Date Received
- July 6, 2016
- Date of Event
- June 7, 2016
- Report Date
- April 19, 2017
- Manufacturer
- MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
- Product Code
- GEX
- PMA / PMN Number
- K081656
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
DEVICE MANUFACTURING DATE IS UNAVAILABLE. RETURN REQUESTED FOR NEUROKIT-400-T10 BUNDLE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. ON 06/10/2016 A MEDTRONIC REPRESENTATIVE PERFORMED A VISUALASE SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. ON 06/13/2016 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE COOLING CATHETER WAS DISPOSED OF AT THE SITE AND WILL NOT BE RETURNED TO MANUFACTURER FOR ANALYSIS. ON 06/14/2016 SOFTWARE INVESTIGATION COMPLETED. FINDINGS ARE THAT THIS WAS NOT A SOFTWARE PROBLEM. SOFTWARE IS FUNCTIONING AS DESIGNED.
CORRECTION: DATE OF DEATH AND CAUSE OF DEATH WERE REPORTED BY THE HOSPITAL AS THE FOLLOWING: ¿DESPITE MAXIMAL MEDICAL THERAPY, PATIENT DEVELOPED SEVERE CEREBRAL EDEMA, AS WELL AS CEREBRAL ISCHEMIA RELATED TO INTRACRANIAL HEMORRHAGE AND SUBSEQUENT SEQUELAE LEADING TO BRAIN DEATH.¿ THE PATIENT WAS DECLARED DECEASED ON (B)(6) 2016. PAST SURGICAL HISTORY: RIGHT TEMPORAL LOBE RESECTION (2003). RIGHT FRONTAL LOBE RESECTION (2005) RIGHT TEMPORAL LOBE RESECTION (2006) EPILEPTOGENIC FOCUS RESECTION (2009). LAST RESECTION RESULTED IN COMPLICATIONS, INCLUDING WOUND INFECTION, MENINGITIS AND AN INTRACRANIAL ABSCESS, REQUIRING RECONSTRUCTION WITH REPLACEMENT WITH AN ARTIFICIAL CRANIAL FLAP. CONCOMITANT MEDICAL PRODUCTS: VCLAS 001-4000 .4MM CORE FIBER 10MM TIP. IS A COMPONENT OF THE BUNDLE NEUROKIT-400-T10. LOT NUMBERS AND CORRESPONDING MANUFACTURE DATES FOR THE VCLAS 001-4000 .4MM CORE FIBER 10MM TIP INSTRUMENTS ARE AS FOLLOWS: LOT #: 151693, MANUFACTURE DATE: 23-JUNE-2015 AND LOT #: 151718, MANUFACTURE DATE: 06-JULY-2015. FURTHER INVESTIGATION IS UNDER WAY REGARDING THIS INCIDENT.
SUMMARY OF ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL ON 29-JUL-2016 NOW PROVIDED: PLACEMENT OF ELECTRODES TO FACILITATE LOCALIZATION OF EPILEPTIC FOCI - DATE OF SURGERY: (B)(6) 2016. AT THE START OF THE PROCEDURE THE LEKSELL FRAME WAS APPLIED TO THE PATIENT AND THE PATIENT UNDERWENT MRI SCAN. MRI SCAN WAS DOWNLOADED INTO STEALTH COMPUTER WORK STATION AND STEREOTACTIC PLANNING WAS PERFORMED. THE PATIENT WAS PLACED IN THE SUPINE POSITION WITH THE LEKSELL FRAME ATTACHED TO THE OPERATING TABLE AND THE NECK FLEXED TO EXPOSE THE SUBOCCIPITAL REGION. TWO DEPTH ELECTRODES WERE PLACED STEREOTACTICALLY TO TARGET AND THE LEKSELL FRAME WAS THEN REMOVED. PATIENT WAS AWOKEN FROM GENERAL ANESTHESIA, EXTUBATED AT THE MRI SUITE AND BROUGHT BACK TO RECOVERY ROOM LETHARGIC, BUT AROUSABLE. LASER ABLATION OF THE EPILEPTOGENIC FOCI - DATE OF SURGERY: (B)(6) 2016. AFTER THE SEIZURE FOCUS WAS LOCALIZED, THE SURGEON PERFORMED LASER THERMAL ABLATION PROCEDURE. THE LASER FIBER SHEATHS WERE PLACED TO TARGET STEREOTACTICALLY USING THE SAME ANCHOR BOLT AS THE ELECTRODE PLACEMENT AND THE LASER FIBERS WERE PLACED WITHIN THE LASER SHEATHS. THE PATIENT WAS THEN TRANSPORTED TO THE MRI SUITE AND UNDERWENT MRI SCAN WHICH SHOWED HEMORRHAGE, MOSTLY IN THE ANTERIOR INSULA, EXTENDING INTO THE HEAD OF THE CAUDATE ON THE RIGHT SIDE WITH EXTENUATION INTO THE RIGHT LATERAL VENTRICLE. SURGEON ELECTED TO PROCEED WITH LASER ABLATION AND PERFORMED ABLATION OF THE RIGHT OPERCULUM. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND UNDERWENT PLACEMENT OF EXTERNAL VENTRICULAR DRAIN (EVD). THE PATIENT TOLERATED THE PROCEDURE WELL, HOWEVER, WAS SLOW TO WAKE UP AND, THEREFORE, WAS TRANSPORTED TO THE PICU STILL INTUBATED. DATE OF SURGERY: (B)(6) 2016 THE SITE ELECTED TO OBTAIN A CT SCAN, THE CT SCAN SHOWED INTERVENTRICULAR HEMATOMA OF BLOOD BILATERAL WITH RIGHT FRONTAL BLOOD IN THE PREVIOUS OPERATIVE SITE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR CRANIOTOMY AND EVACUATION OF INTERVENTRICULAR HEMATOMA, WHICH INCLUDED PLACEMENT OF A SECOND EVD ON THE CONTRALATERAL SIDE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS THEN TRANSPORTED TO THE INTENSIVE CARE UNIT STILL INTUBATED AND UNDER GENERAL ANESTHESIA. INTRACRANIAL HEMORRHAGE IS A KNOWN INHERENT RISK TO ANY INVASIVE CRANIAL PROCEDURE. FURTHER INVESTIGATION IS UNDER WAY REGARDING THIS INCIDENT.
ALTHOUGH A SPECIFIC CAUSE OF THE REPORTED INCIDENT WAS UNCONFIRMED AS THE PART WAS NOT RECEIVED TO THE MANUFACTURER, AN INVESTIGATION WAS COMPLETED VIA A SITUATION ANALYSIS (SA) INVESTIGATION. THE SA INVESTIGATION CONCLUDED THE FOLLOWING: 1. THE EVIDENCE DID NOT SUGGEST THE COOLING CATHETER SYSTEM (CCS) TIP WAS NON-CONFORMING OR SHARPER THAN INTENDED. 2. THE TEAM FURTHER CONCLUDED THAT THE EVIDENCE DID NOT SUGGEST THE BEND IN THE CCS TRAJECTORY WAS CAUSED BY A NON-CONFORMING OR MALFUNCTION OF THE CCS. OVERALL, THE TEAM DID NOT IDENTIFY A DEFINITIVE ROOT CAUSE ASSOCIATED WITH THE MATERIALS, THE MANUFACTURING, OR THE INTENDED USE OF THE CCS. THE PATIENT SAFETY RISK WAS DETERMINED TO REMAIN UNCHANGED.
A MEDTRONIC REPRESENTATIVE REPORTED THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED A CEREBRAL HEMORRHAGE WHILE UNDERGOING A LASER INTERSTITIAL THERMAL THERAPY (LITT) PROCEDURE TO TREAT EPILEPSY USING A VISUALASE THERMAL THERAPY SYSTEM. ON 10-JUN-2016 THE MEDTRONIC REPRESENTATIVE WAS INFORMED THAT ON (B)(6) 2016, THE PATIENT EXPIRED. PATIENT WAS AFFECTED WITH A BRAIN BLEED. THE SURGEON ALLEGED THAT THE POINTED CATHETER WAS THE CAUSE OF BLEEDING. FURTHER INVESTIGATION IS BEING CONDUCTED TO DETERMINE THE CAUSE OF DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426438 | SYSTEM 9735542 15W VISUALASE | POWERED LASER SURGICAL INSTRUMENT | GEX | MEDTRONIC NAVIGATION, INC. (LOUISVILLE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Death| L| R |