NAVIGATION SOFTWARE CRANIAL 3.1
Report
- Report Number
- 8043933-2023-00086
- Event Type
- Injury
- Date Received
- December 20, 2023
- Date of Event
- November 28, 2023
- Report Date
- February 2, 2024
- Manufacturer
- BRAINLAB AG
- Product Code
- HAW
- UDI-DI
- 04056481132439
- PMA / PMN Number
- K192703
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A BIOPSY PATH WAS PERFORMED IN ANOTHER LOCATION THAN INTENDED IN THE PATIENT'S BRAIN WITH THE BRAINLAB DEVICE INVOLVED, ALTHOUGH ACCORDING TO THE HOSPITAL. -DESPITE THE BIOPSY NEEDLE WAS NOT INSERTED TO THE INTENDED DEPTH WITH NAVIGATION, BUT ADVANCED APPROX. 16MM DEEPER THAN PLANNED INTO CRIBIFORM PLATE, WHICH LED TO A LARGER DEGREE OF PNEUMOCEPHALUS THAN EXPECTED, THERE WAS NO ACTIVE LEAK AND NO MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THIS EFFECT. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED (SAMPLE OBTAINED AT TARGET WAS DETERMINED TO BE ABNORMAL/NECROTIC). - THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENT, BUT IT LEADS TO AN ADDED RISK OF INFECTION. - THERE WAS NO ACTUAL HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO THIS ISSUE TO DATE (ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGED BY 30-60MIN). - THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE; HOSPITALIZATION WAS NOT PROLONGED EITHER. H6, H7: A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC EVENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT TO THE FDA UPON COMPLETION OF INVESTIGATION.
B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A BIOPSY PATH WAS PERFORMED IN A DIFFERENT LOCATION IN THE BRAIN THAN ANTICIPATED AND PLANNED WITH THE BRAINLAB NAVIGATION INVOLVED, DESPITE ACCORDING TO THE SURGEON: THE BIOPSY NEEDLE WAS NOT INSERTED TO THE INTENDED DEPTH WITH NAVIGATION, BUT ADVANCED REPORTEDLY APPROX. 16MM DEEPER THAN PLANNED INTO CRIBRIFORM PLATE, WHICH LED TO A LARGER DEGREE OF PNEUMOCEPHALUS THAN EXPECTED, HOWEVER, THERE WAS NO ACTIVE LEAK AND NO MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THIS EFFECT THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED (SAMPLE OBTAINED AT TARGET WAS DETERMINED TO BE ABNORMAL/NECROTIC) THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENT, BUT IT LEADS TO AN ADDED RISK OF INFECTION THERE WAS NO ACTUAL HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO THIS ISSUE TO DATE (ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGED BY 30-60MIN) THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE; HOSPITALIZATION WAS NOT PROLONGED EITHER H6: ACCORDING TO THE RESULTS OF THIS TECHNICAL INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE DEVIATED BIOPSY COLLECTION WITH THE AID OF NAVIGATION DEVIATING BY REPORTEDLY CA. 16MM (ACCORDING TO IMAGE DATA CA. 11-13 MM) DEEP FROM INTENDED TARGET IS A COMBINATION OF: A POINT ACQUISITION BY THE USER FOR THE PATIENT ANATOMY REGISTRATION TO NAVIGATION OUTSIDE OF BRAINLAB RECOMMENDATIONS, I.E. IN AREAS OF POTENTIAL SKIN SHIFT (EYE ON LEFT SIDE) AND LACK OF POINTS COLLECTED EVENLY OVER THE ENTIRE FACE. IN THIS CASE POINTS WERE COLLECTED WITH THE Z-TOUCH ON THE LEFT SIDE ONLY AND ON/AROUND THE EYE WHICH IS PRONE TO SKIN SHIFT. THIS CAUSED THE NAVIGATION SOFTWARE TO NOT FIND AN AS ACCURATE MATCH IN THE REGION OF INTEREST AS DESIRED FOR THIS SPECIFIC PROCEDURE IN BETWEEN THE PREOPERATIVE IMAGE DATASET AND ACTUAL PATIENT ANATOMY. - AN INADEQUATE PATIENT SCAN USED FOR NAVIGATION. IN THIS CASE, MR DATA SET WITH 4MM SLICE THICKNESS WAS UTILIZED TO NAVIGATE (LESS THAN OR EQUAL TO 2MM IS RECOMMENDED BY BRAINLAB). THE GREATER THAN 2MM SLICE THICKNESS DOES NOT MAP ANATOMY EXACTLY, AND THE NAVIGATION SYSTEM CANNOT DISPLAY THE INSTRUMENT POSITION ACCURATELY ON PATIENT ANATOMY (AS THE SCAN DOES NOT CONTAIN THAT LEVEL OF ANATOMICAL DETAIL). THIS LIKELY LED TO USAGE OF THE INSTRUMENT (BIOPSY NEEDLE) NOT IN THE DESIRED LOCATION. THE DIFFERENCE BETWEEN THE CT AND MR DATA SETS CAN E.G. BE SEEN BY THE SINGLE VERIFICATION POINT COLLECTED BY THE SOFTWARE WITH THE CALIBRATED NEEDLE THAT SHOWS ABOVE THE PATIENT ANATOMY ON THE REGISTERED CT DATA SET AND ON PATIENT ANATOMY/CLOSER TO THE PLANNED ENTRY POINT ON THE NAVIGATED MR (WITH 4MM SLICE THICKNESS), WHICH WOULD ALSO ACCOUNT FOR THE DEEPER THAN EXPECTED DEVIATION. - A BIOPSY NEEDLE WAS CALIBRATED WITH STARLINK CLAMP AND ARRAY, WHICH IS NOT RECOMMENDED, SINCE IT IS A FLEXIBLE INSTRUMENT, AND A SHIFT IN THE INSTRUMENT CANNOT BE TRACKED BY THE NAVIGATION SYSTEM. IMAGE DATA SHOW THAT THE TRAJECTORY IS AT THE EDGE OF THE BURR HOLE/NEAR BONE, WHICH COULD HAVE LED TO BENDING OF THE NEEDLE WHEN MAKING CONTACT WITH THE BONE DURING INSERTION AND HAVE LED TO A DEVIATION OF THE NEEDLE TIP. FURTHER, THE NEEDLE WAS USED FOR THIS PROCEDURE WITHOUT A STOPPER, WHICH IS NOT RECOMMENDED. THUS, THE ACTUAL DEPTH OF THE NEEDLE COULD NOT BE TRACKED BY THE USER, WHICH ALLOWED FOR A TRAJECTORY BEYOND THE EXPECTED TARGET. APPARENTLY, A DEVIATION FROM PLANNED TARGET WAS DISPLAYED TO THE USER ON THE NAVIGATION SCREEN (A WARNING WAS SHOWN DURING BIOPSY SAMPLE COLLECTION THAT THE NAVIGATED BIOPSY NEEDLE IS 6.8MM BEYOND THE TARGET), HOWEVER THE FULL EXTENT OF THE DEVIATION BETWEEN THE ACTUAL ANATOMY LOCATION DURING THE SURGERY AND THE REGISTERED PRE-OPERATIVE PATIENT IMAGE SCAN OR THE NAVIGATED MR DATA SET DISPLAYED BY THE NAVIGATION WAS NOT RECOGNIZED BY THE USER WITH THE REQUIRED THOROUGH VERIFICATION OF THE REGISTRATION ACCURACY, NOR WITH THE NECESSARY CONTINUED VERIFICATION OF NAVIGATION ACCURACY AFTER DRAPING, AND THROUGHOUT THE PROCEDURE BEFORE APPLYING SIGNIFICANT INVASIVE SURGICAL ACTIONS. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE (NAVIGATION). CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE. H7: BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.
A CRANIAL SURGERY FOR A BIOPSY, TO ONLY RECEIVE A DIAGNOSTIC SAMPLE OF A LESION OF 44.1CM3 IN VOLUME, LOCATED LEFT FRONTAL AT A DEPTH OF APPROX. 60 MM IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAV. SW CRANIAL 3.1.5 WITH VARIOGUIDE (ON (B)(6), 2023). ONE BIOPSY PASS WITH 12 SAMPLES AT 3 DEPTHS WAS INTENDED. PRE-OPERATIVELY A CT AND TWO MRI SCANS WERE ACQUIRED TEN DAYS BEFORE THE SURGERY (ONE OF WHICH CONTAINED MOTION ARTIFACT BUT WAS STILL USED DUE TO THE LARGE SIZE OF THE TARGET), AND A TRAJECTORY WAS PLANNED. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, WITH THE HEAD TURNED SLIGHTLY TO THE PATIENT'S RIGHT, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER - PERFORMED THE PATIENT REGISTRATION ON THE BEFOREHAND FUSED PRE-OPERATIVE CT AND MRIS BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE SOFTOUCH AND Z-TOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE REGISTRATION ACCURACY, JUDGING IT AS GOOD/VERY GOOD, AND ACCEPTED IT TO PROCEED. - PLANNED THE SKIN INCISION ENTRY POINT WITH AID OF NAVIGATION, AND MARKED IT WITH A PEN ON THE SKIN. - DRAPED THE PATIENT, AND EXCHANGED THE UNSTERILE NAVIGATION REFERENCE ARRAY FOR A STERILE ONE. - ATTEMPTED TO ALIGN THE VARIOGUIDE ROUGHLY TO THE PREOPERATIVELY PLANNED TRAJECTORY, BUT REALIZED THAT WAS UNATTAINABLE DUE TO THE GIVEN LOCATION OF THE PLANNED ENTRY AND THE HEAD HOLDER ATTACHMENT SITE. - PLANNED A NEW TRAJECTORY INTRAOPERATIVELY USING THE BRAINLAB POINTER . - ALIGNED THE VARIOGUIDE ROUGHLY TO THE NEW TRAJECTORY, AND PERFORMED SKIN INCISION AT THE MARKED LOCATION. - CREATED THE BURR HOLE WITHOUT AID OF NAVIGATION. - EXTENDED THE CRANIOTOMY. - COMPLETED VARIOGUIDE ALIGNMENT AND INTRODUCED THE BIOPSY NEEDLE INTO THE CAMERA FIELD OF VIEW, BUT THE CAMERA DID NOT RECOGNIZE THE NEEDLE'S GEOMETRY. - OBTAINED A NEW BIOPSY NEEDLE AND INTRODUCED IT INTO THE CAMERA FIELD OF VIEW, BUT THE CAMERA AGAIN DID NOT RECOGNIZE THE NEEDLE'S GEOMETRY. - ATTACHED THE STARLINK CLAMP AND ARRAY TO THE BIOPSY NEEDLE, CALIBRATED THE INSTRUMENT TO NAVIGATION, AND VERIFIED ACCURACY OF THE INSTRUMENT TIP ON THE PATIENT ANATOMY. - INSERTED THE NAVIGATED BIOPSY NEEDLE THROUGH THE VARIOGUIDE FOLLOWING THE PLANNED TRAJECTORY TO TARGET DEPTH. - TOOK 12 SAMPLES AT 3 DIFFERENT DEPTHS (AT TARGET DEPTH FROM FOUR QUADRANTS, AS WELL AS 10MM AND 20MM RETRACTED FROM TARGET DEPTH IN FOUR QUADRANTS) . ACCORDING TO THE HOSPITAL/NEUROSURGEON: -THE BIOPSY NEEDLE WAS NOT INSERTED TO THE INTENDED DEPTH WITH NAVIGATION, BUT ADVANCED APPROX. 16MM DEEPER THAN PLANNED INTO CRIBIFORM PLATE, WHICH LED TO A LARGER DEGREE OF PNEUMOCEPHALUS THAN EXPECTED, HOWEVER, THERE WAS NO ACTIVE LEAK AND NO MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THIS EFFECT. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED (SAMPLE OBTAINED AT TARGET WAS DETERMINED TO BE ABNORMAL/NECROTIC). - THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENT, BUT IT LEADS TO AN ADDED RISK OF INFECTION. - THERE WAS NO ACTUAL HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO THIS ISSUE TO DATE (ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGED BY 30-60MIN). - THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE; HOSPITALIZATION WAS NOT PROLONGED EITHER.
A CRANIAL SURGERY FOR A BIOPSY, TO ONLY RECEIVE A DIAGNOSTIC SAMPLE OF A LESION OF 44.1CM3 IN VOLUME, LOCATED LEFT FRONTAL AT A DEPTH OF APPROX. 60 MM IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAV. SW CRANIAL 3.1.5 WITH VARIOGUIDE. ONE BIOPSY PASS WITH 12 SAMPLES AT 3 DEPTHS WAS INTENDED. PRE-OPERATIVELY A CT AND TWO MRI SCANS WERE ACQUIRED TEN DAYS BEFORE THE SURGERY (ONE OF WHICH CONTAINED MOTION ARTIFACT BUT WAS STILL USED DUE TO THE LARGE SIZE OF THE TARGET), AND A TRAJECTORY WAS PLANNED. DURING THE PROCEDURE, THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER, WITH THE HEAD TURNED SLIGHTLY TO THE PATIENT'S RIGHT, AND ATTACHED THE REFERENCE ARRAY FOR NAVIGATION TO THE HEAD HOLDER PERFORMED THE PATIENT REGISTRATION ON THE BEFOREHAND FUSED PRE-OPERATIVE CT AND MRIS BY ACQUIRING SURFACE MATCHING REGISTRATION POINTS WITH THE SOFTOUCH AND Z-TOUCH REGISTRATION POINTER ON THE PATIENT HEAD'S SKIN, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE REGISTRATION ACCURACY, JUDGING IT AS GOOD/VERY GOOD, AND ACCEPTED IT TO PROCEED PLANNED THE SKIN INCISION ENTRY POINT WITH AID OF NAVIGATION, AND MARKED IT WITH A PEN ON THE SKIN DRAPED THE PATIENT, AND EXCHANGED THE UNSTERILE NAVIGATION REFERENCE ARRAY FOR A STERILE ONE ATTEMPTED TO ALIGN THE VARIOGUIDE ROUGHLY TO THE PREOPERATIVELY PLANNED TRAJECTORY, BUT REALIZED THAT WAS UNATTAINABLE DUE TO THE GIVEN LOCATION OF THE PLANNED ENTRY AND THE HEAD HOLDER ATTACHMENT SITE PLANNED A NEW TRAJECTORY INTRAOPERATIVELY USING THE BRAINLAB POINTER (AND 60MM OFFSET) ALIGNED THE VARIOGUIDE ROUGHLY TO THE NEW TRAJECTORY, AND PERFORMED SKIN INCISION AT THE (NEWLY) MARKED LOCATION CREATED THE BURR HOLE WITHOUT AID OF NAVIGATION (DID NOT DRILL THROUGH VARIOGUIDE) COMPLETED VARIOGUIDE ALIGNMENT AND INTRODUCED THE BIOPSY NEEDLE INTO THE CAMERA FIELD OF VIEW, BUT THE CAMERA DID NOT RECOGNIZE THE NEEDLE'S GEOMETRY, AND SINCE THE NEEDLE WAS HITTING BONE/SKULL, EXTENDED THE CRANIOTOMY UNTIL THE CRANIOTOMY ALLOWED INSERTION OF NEEDLE WITHOUT COLLISION WITH BONE/SKULL OBTAINED A NEW BIOPSY NEEDLE AND INTRODUCED IT INTO THE CAMERA FIELD OF VIEW, BUT THE CAMERA AGAIN DID NOT RECOGNIZE THE NEEDLE'S GEOMETRY ATTACHED THE STARLINK CLAMP AND ARRAY TO THE BIOPSY NEEDLE, CALIBRATED THE INSTRUMENT TO NAVIGATION, AND VERIFIED ACCURACY OF THE INSTRUMENT TIP ON THE PATIENT ANATOMY INSERTED THE NAVIGATED BIOPSY NEEDLE THROUGH THE VARIOGUIDE FOLLOWING THE PLANNED TRAJECTORY TO TARGET DEPTH TOOK 12 SAMPLES AT 3 DIFFERENT DEPTHS (AT TARGET DEPTH FROM FOUR QUADRANTS, AS WELL AS 10MM AND 20MM RETRACTED FROM TARGET DEPTH IN FOUR QUADRANTS) A POST-OPERATIVE SCAN SHOWED AN UNEXPECTED DEGREE OF PNEUMOCEPHALUS, WHICH LED THE SURGEON TO SUSPECT THAT THE BIOPSY NEEDLE WAS INSERTED DEEPER THAN THE PLANNED/INTENDED TARGET. ACCORDING TO THE SURGEON: THE BIOPSY NEEDLE WAS NOT INSERTED TO THE INTENDED DEPTH WITH NAVIGATION, BUT ADVANCED APPROX. 16MM DEEPER THAN PLANNED INTO CRIBRIFORM PLATE, WHICH LED TO A LARGER DEGREE OF PNEUMOCEPHALUS THAN EXPECTED, HOWEVER, THERE WAS NO ACTIVE LEAK AND NO MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THIS EFFECT THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED (SAMPLE OBTAINED AT TARGET WAS DETERMINED TO BE ABNORMAL/NECROTIC) THERE WAS NO DIRECT (OR INCREASED) RISK OF HARM TO A CRITICAL STRUCTURE DUE TO THE DEVIATING PLACEMENT, BUT IT LEADS TO AN ADDED RISK OF INFECTION THERE WAS NO ACTUAL HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO THIS ISSUE TO DATE (ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGED BY 30-60MIN) THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE; HOSPITALIZATION WAS NOT PROLONGED EITHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2205485 | NAVIGATION SOFTWARE CRANIAL 3.1 | IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW | HAW | BRAINLAB AG | 22216-02C | 04056481132439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |