GALAXY G3 MINI 2.5MM X 4.5CM
Report
- Report Number
- 3008114965-2018-00835
- Event Type
- Malfunction
- Date Received
- December 14, 2018
- Date of Event
- December 5, 2018
- Report Date
- December 5, 2018
- Manufacturer
- SEE H.10
- Product Code
- KRD
- UDI-DI
- 10886704080275
- PMA / PMN Number
- K171862
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THE PURPOSE OF THIS MDR IS TO DOCUMENT THE ADDITIONAL DEVICE OBSERVATION MADE ON 12/19/2018, BY THE J&J JAPAN AFFILIATES THAT THE MARKER BAND ON THE DEVICE WAS OFFSET/OUT OF POSITION. [ADDITIONAL INFORMATION]: PRELIMINARY OBSERVATIONAL IMAGES WERE TAKEN AND FORWARDED BY THE J&J JAPAN AFFILIATES. THE IMAGES REVEALED THAT THE FLUOROSCOPY MARKER ON THE 2.5MM X 4.5CM GALAXY G3 MINI COIL WAS OFFSET/OUT OF POSITION. MARKERS 1 THROUGH 3 AND MARKER 5 HAVE MEASURED LENGTH OF 5 MM; THE FOURTH MARKER HAS A MEASURED LENGTH OF 4.5MM. THE SPACING GAPS BETWEEN THE FIRST/SECOND, SECOND/THIRD ARE CONSISTENT AT 4MM WHILE THE GAPS BETWEEN THE THIRD/FOURTH AT 5MM, AND FOURTH/ FIFTH MAKERS AT 14MM. FURTHER ANALYSIS WITH THE PRODUCT ANALYSIS LAB IS PENDING THE RETURN OF THE 2.5MM X 4.5CM GALAXY G3 MINI COIL. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE INTERNAL CAROTID (IC) ARTERY TERMINAL, THE PACKAGE OF THE 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045 / L12615) WAS OPENED AND THE MARKER ON THE DETACHMENT POINT WAS LINED UP AND THE DETACHMENT CONTROL BOX WAS PRESSED THREE TIMES, BUT THE COIL COULD NOT BE DETACHED. THE COIL WAS RESHEATHED AND REMOVED STILL ATTACHED TO THE DELIVERY SYSTEM. NO ADDITIONAL COIL WAS USED FOR THE PROCEDURE. IT WAS CONFIRMED THAT ALL CONNECTIONS TO THE DETACHMENT CONTROL BOX PROPERLY FIT AND EXCESSIVE FORCE WAS NOT APPLIED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE 2.5MM X 4.5CM GALAXY G3 MINI COIL WAS RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. PRELIMINARY OBSERVATIONAL IMAGES WERE TAKEN AND FORWARDED BY THE J&J JAPAN AFFILIATES. THE IMAGES REVEALED THAT THE FLUOROSCOPY MARKER ON THE 2.5MM X 4.5CM GALAXY G3 MINI COIL WAS OFFSET/OUT OF POSITION. MARKERS 1 THROUGH 3 AND MARKER 5 HAVE MEASURED LENGTH OF 5 MM; THE FOURTH MARKER HAS A MEASURED LENGTH OF 4.5MM. THE SPACING GAPS BETWEEN THE FIRST/SECOND, SECOND/THIRD ARE CONSISTENT AT 4MM WHILE THE GAPS BETWEEN THE THIRD/FOURTH AT 5MM, AND FOURTH/ FIFTH MAKERS AT 14MM. IT WAS CONFIRMED THAT NO RESISTANCE WAS FELT BETWEEN THE DEVICE POSITIONING UNIT (DPU) AND THE INTRODUCER, THE ROTATING HEMOSTAT VALVE (RHV), OR WITH THE MICROCATHETER. THE PHYSICIAN DID NOT NOTICE THAT THE MARKER BAND POSITION WAS OFFSET. IT WAS ALSO CONFIRMED THAT THE PHYSICIAN DID NOT GRIP THE DEVICE WITH FORCEPS AND NOT TOO MUCH PRESSURE WAS APPLIED TO THE DPU. FURTHER ANALYSIS WITH THE PRODUCT ANALYSIS LAB IS PENDING THE RETURN OF THE 2.5MM X 4.5CM GALAXY G3 MINI COIL. INVESTIGATION SUMMARY: THE DISTANCE FROM THE DISTAL END OF THE STRAIN RELIEF VALVE TO THE DISTAL END OF THE DISTAL FLUORO MARKER WAS APPROXIMATELY 40.2 CM. THE SPECIFICATION FOR A GALAXY G3 MINI 2.5MM X 4.5CM IS 39 CM +/- 0.5 CM. THE FLUORO MARKERS WERE IDENTIFIED FROM THE MOST PROXIMAL TO THE MOST DISTAL WITH EACH MARKER MEASURED. THE GAPS BETWEEN THE MARKERS WERE ALSO IDENTIFIED FROM MOST PROXIMAL TO MOST DISTAL AND MEASURED. THE LAST GAP BETWEEN MARKERS 4 AND 5 WAS OBSERVED TO BE OUT OF SPECIFICATION. THE GAP LENGTH SPECIFICATION IS 4 ¿ 6 MM. THE SPECIFICATION OF THE LENGTH OF ONE MARKER IS 5 MM +/- 1 MM. ALL MARKERS ARE WITHIN LENGTH SPECIFICATION. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE FIRST FOUR MARKERS 1 THROUGH 4 AND THE GAPS BETWEEN THEM WERE NOTED WITHOUT ANY UNUSUAL DAMAGE. THE GAP BETWEEN THE MARKER 4 AND MARKER 5 WAS NOTED TO HAVE A SHRINKING IRREGULARITY. THE DISTAL END OF MARKER 5 APPEARED TO HAVE BEEN PRESSED PROXIMALLY, INDICATED BY MARKER CREASES PERPENDICULAR TO THE CORE WIRE. NON-MARKER OBSERVATIONS: THE RETURNED DEVICE REMOVED FROM THE PACKAGING. NO KINKS WERE OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE. THE EMBOLIC COIL WAS SEEN IN THE TRANSLUCENT INTRODUCER. THE LENGTH OF THE COIL WAS MEASURED TO BE APPROXIMATELY 4.5 CM, WHICH IS ACCURATE TO THE PRODUCT TYPE THAT WAS RECORDED. THE DEVICE WAS THEN VIEWED UNDER A LAB MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. THE COIL HAD LEFT A DARK PATTERN ON THE INSIDE WALL OF THE INTRODUCER. THE EMBOLIC COIL CAN BE SEEN DETACHED FROM THE DPU. RESISTANCE WAS FELT WHEN THE DPU CORE WIRE COULD BE RETRACTED. THE DPU COULD NOT ADVANCE TO THE PROXIMAL END OF THE EMBOLIC COIL BECAUSE THE RESISTANCE WAS INCREASED WHEN THE DPU WAS ATTEMPTED TO MOVE DISTALLY. THE VIEW OF THE DISTAL OUTER SHEATH WAS OBSTRUCTED BY THE INTRODUCER; HOWEVER, IT APPEARS THAT THE DISTAL OUTER SHEATH HAD SOFTENED, INDICATING THAT THE RESISTANCE HEATING (RH) COIL HAD HEATED AND THE DETACHMENT PROCESS HAD BEEN INITIATED. WHEN THE DEVICE WAS UNZIPPED IN THE LAB, THE DPU CORE WIRE FELT ROUGH. UNDER THE MICROSCOPE, IT WAS SEEN THAT THE OUTER LAYER OF THE DPU WAS UNEVEN. THE UNEVEN AREA OF THE DPU CORE WIRE HAD STARTED AT APPROXIMATELY 148 CM AND CONTINUED DISTALLY TO THE RESHEATHING TOOL. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE DEVICE WAS CONNECTED TO LAB MULTIMETER 70042-04D AND THE RESISTANCE OF THE DEVICE WAS MEASURED TO BE 52.5 OHMS, WHICH IS SPECIFICATION OF 48.5 ¿ 56 OHMS. THE DEVICE WAS THEN CONNECTED TO LAB EQUIPMENT: ENPOWER DETACHMENT CONTROL BOX (LOT#: C46055) AND ENPOWER CONTROL CABLE (LOT#:C10702). THE POWER WAS TURNED ON AND THE SYSTEM READY LIGHT STEADILY ILLUMINATED, INDICATING THAT THE DEVICE WAS RECOGNIZED AND ABLE TO INITIATE THE DETACHMENT PROCESS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L12615) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. INVESTIGATION CONCLUSION: THE REPORTED ISSUE OF THE 2.5MM X 4.5CM GALAXY G3 MINI COIL FAILURE TO DETACH WAS NOT CONFIRMED AS THE DEVICE WAS RETURNED WITH THE EMBOLIC COIL DETACHED FROM THE DPU INSIDE THE INTRODUCER SHEATH. THE SOFTENED DISTAL OUTER SHEATH INDICATES THAT THE COIL WAS DETACHED THERMALLY BY NORMAL USE OF A DETACHMENT CONTROL BOX. THE COMPLAINT OF DEVICE POSITIONING UNIT (THERMO-MECHANICAL DETACHMENT SYSTEM) FLUORO SAVER MARKERS - OUT OF POSITION IS CONFIRMED. THE DISTANCE FROM THE DISTAL END OF THE STRAIN RELIEF VALVE TO THE DISTAL END OF THE DISTAL FLUORO MARKER WAS APPROXIMATELY 40.2 CM. THE SPECIFICATION FOR A GALAXY G3 MINI 2.5MM X 4.5CM IS 39 CM +/- 0.5 CM. THE DISTAL MARKER WAS OUT OF POSITION, DISTALLY, BY 7 MM. THE NONCONFORMITY OF THE DISTAL FLUORO MARKER IS ADDRESSED BY A CORRECTIVE AND PREVENTIVE ACTION (CAPA). THE CAPA IS UNRELATED TO THE COIL DETACHMENT FAILURES. THE POSITION OF THE DISTAL FLUORO MARKER IS NOT A POTENTIAL CAUSE OF THE EMBOLIC COIL FAILING TO DETACH. FAILURE TO DETACH IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTION FOR USE (IFU) CONTAINS SEVERAL PRECAUTIONS RELATED TO THIS ISSUE AND INCLUDES INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND/OR DEVICE MANIPULATION/INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 1/7/2019 AND 1/9/2019. UPDATED SECTIONS: CONCOMITANT MEDICAL PRODUCTS, THE INITIAL REPORTER TITLE, FIRST AND LAST NAMES WERE ADDED. INITIAL REPORTER ADDRESS (LINES 1 AND 2) WERE UPDATED. INITIAL REPORTER CITY WAS UPDATED. THE INITIAL REPORTER PHONE: (B)(6). INITIAL REPORTER OCCUPATION, DATE REC¿D BY MFR, PMA/510K, IF FOLLOW-UP, WHAT TYPE AND DEVICE EVALUATED BY MFR. [ADDITIONAL INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE INTERNAL CAROTID (IC) ARTERY TERMINAL, THE PACKAGE OF THE 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045 / L12615) WAS OPENED AND THE MARKER ON THE DETACHMENT POINT WAS LINED UP AND THE DETACHMENT CONTROL BOX WAS PRESSED THREE TIMES, BUT THE COIL COULD NOT BE DETACHED. THE COIL WAS RESHEATHED AND REMOVED STILL ATTACHED TO THE DELIVERY SYSTEM. NO ADDITIONAL COIL WAS USED FOR THE PROCEDURE. IT WAS CONFIRMED THAT ALL CONNECTIONS TO THE DETACHMENT CONTROL BOX PROPERLY FIT AND EXCESSIVE FORCE WAS NOT APPLIED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE 2.5MM X 4.5CM GALAXY G3 MINI COIL WAS REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. PRELIMINARY OBSERVATIONAL IMAGES WERE TAKEN AND FORWARDED BY THE J&J JAPAN AFFILIATES. THE IMAGES REVEALED THAT THE FLUOROSCOPY MARKER ON THE 2.5MM X 4.5CM GALAXY G3 MINI COIL WAS OFFSET/OUT OF POSITION. MARKERS 1 THROUGH 3 AND MARKER 5 HAVE MEASURED LENGTH OF 5 MM; THE FOURTH MARKER HAS A MEASURED LENGTH OF 4.5MM. THE SPACING GAPS BETWEEN THE FIRST/SECOND, SECOND/THIRD ARE CONSISTENT AT 4MM WHILE THE GAPS BETWEEN THE THIRD/FOURTH AT 5MM, AND FOURTH/ FIFTH MAKERS AT 14MM. IT WAS CONFIRMED THAT NO RESISTANCE WAS FELT BETWEEN THE DEVICE POSITIONING UNIT (DPU) AND THE INTRODUCER, THE ROTATING HEMOSTAT VALVE (RHV), OR WITH THE MICROCATHETER. THE PHYSICIAN DID NOT NOTICE THAT THE MARKER BAND POSITION WAS OFFSET. IT WAS ALSO CONFIRMED THAT THE PHYSICIAN DID NOT GRIP THE DEVICE WITH FORCEPS AND NOT TOO MUCH PRESSURE WAS APPLIED TO THE DPU. FURTHER ANALYSIS WITH THE PRODUCT ANALYSIS LAB IS PENDING THE RETURN OF THE 2.5MM X 4.5CM GALAXY G3 MINI COIL. THE PRODUCT WAS RECEIVED BY CERENOVUS PRODUCT ANALYSIS LAB ON 01/10/2019 AND IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). INITIAL REPORTER INFORMATION SUCH AS THE NAME, PHONE AND EMAIL ADDRESS ARE NOT AVAILABLE/REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L12615) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE INTERNAL CAROTID (IC) ARTERY TERMINAL, THE PACKAGE OF THE 2.5MM X 4.5CM GALAXY G3 MINI COIL (GLM925045/L12615) WAS OPENED AND THE MARKER ON THE DETACHMENT POINT WAS LINED UP AND THE DETACHMENT CONTROL BOX WAS PRESSED THREE TIMES, BUT THE COIL COULD NOT BE DETACHED. THE COIL WAS RESHEATHED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE 2.5MM X 4.5CM GALAXY G3 MINI COIL WAS REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1003693 | GALAXY G3 MINI 2.5MM X 4.5CM | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION | KRD | SEE H.10 | L12615 | 10886704080275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SL-10® MICROCATHETER, STRYKER |