GALAXY G3 XSFT 3MM X 4CM
Report
- Report Number
- 3008114965-2018-00782
- Event Type
- Malfunction
- Date Received
- November 9, 2018
- Date of Event
- October 23, 2018
- Report Date
- October 23, 2018
- Manufacturer
- SEE H.10
- Product Code
- KRD
- UDI-DI
- 10886704077688
- PMA / PMN Number
- K150319
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER¿S REF. NO: (B)(4). [ADDITIONAL EVENT INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING AN ANEURYSM AT THE BASILAR TIP, WHEN THE PHYSICIAN OPENED THE PACKAGE TO THE GALAXY G3 XSFT 3MM X 4CM COIL (GLX120304 / L12525), HE NOTICED THAT THE DEVICE HAD A MISSING FLUORO SAVER MARKER. THERE WERE SUPPOSED TO BE FIVE (5) FLUORO SAVER MARKERS ON THE DEVICE, BUT ON THIS GALAXY G3 XSFT 3MM X 4CM COIL, THERE WERE ONLY 4 MARKERS. THE ISSUE WAS NOTICED BEFORE THE DEVICE WAS INSERTED INTO THE PATIENT¿S BODY. THE PHYSICIAN MADE THE DECISION TO USE THE COIL. IT WAS REPORTED THAT THE COIL WAS STILL WITHIN THE MICROCATHETER (EXCELSIOR®SL-10®, 150CM, STRYKER) WHEN FLUORO WAS INITIATED. THERE WAS NO REPORT OF RESISTANCE EXPERIENCED DURING THE ADVANCEMENT OR THE WITHDRAWAL OF THE DEVICE THROUGH THE MICROCATHETER. INFORMATION RELATED TO THE BRAND, SIZE OF THE ROTATING HEMOSTAT (RHV) AND WHETHER IT WAS ADEQUATELY OPENED TO ALLOW FOR THE PASSAGE OF THE DEVICE DURING USE WERE NOT AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TOTAL OF FIVE (5) SPECTRA COILS IMPLANTED IN THE PATIENTS. IT WAS CONFIRMED THAT THERE WAS NO PRODUCT MALFUNCTION OR ADVERSE EVENT RELATED TO THE USE OF THE DEVICE. IT WAS CONFIRMED THAT THERE WERE NO ANOMALIES WITH THE OTHER FOUR (4) COILS; THEY ALL HAVE THE COMPLETE NUMBER OF FLUORO SAVER MARKERS ON THEM. THE PROCEDURE WAS SUCCESSFULLY 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 PRODUCT WAS RECEIVED BY THE CERENOVUS FAILURE ANALYSIS LAB ON 11/02/2018. BASED ON THE PRELIMINARY ANALYSIS, THE DEVICE POSITIONING UNIT (DPU) APPEARED TO BE DAMAGE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO CONFIRMED DAMAGE ON THE DPU PRIOR TO USE. THE EVALUATION AND ANALYSIS OF THE RETURNED PRODUCT HAS NOT YET BEEN COMPLETED. WHEN THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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. (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE BASILAR TIP, THE PHYSICIAN OPENED THE PACKAGE OF THE GALAXY G3 XSFT (GLX120304/L12525) AND CONFIRMED THAT THERE APPEARED TO BE ONLY FOUR FLUORO SAVER MARKERS INSTEAD OF FIVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THE COIL WAS STILL WITHIN THE MICROCATHETER WHEN FLUORO WAS INITIATED AND THERE WAS NO INDICATION OF PRODUCT MALFUNCTION OR ADVERSE EVENT DURING USE OF THE DEVICE IN THE PATIENT. THERE WAS NO REPORT OF RESISTANCE DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE THROUGH THE RHV, OR EXCELSIOR SL10 MICROCATHETER. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH A CONSTANT CATHETER FLUSH BEING MAINTAINED. NO OTHER VISIBLE DEFECTS OR DAMAGES WERE NOTED ON THE PRODUCTS PRIOR TO THE EVENT. PRELIMINARY IMAGES WERE FORWARDED FOR REVIEW BY THE J&J JAPAN AFFILIATES. THE IMAGES SHOWING WHAT APPEARED TO BE THE SECOND AND THIRD MOST PROXIMAL MARKERS CONNECTED WITH NO GAP BETWEEN THEM. THE GAPS BETWEEN THE FIRST AND SECOND MARKERS AND THIRD AND FOURTH MARKERS APPEARED LARGER THAN THE GAP BETWEEN THE FOURTH AND FIFTH MOST PROXIMAL MARKERS. THE DEVICE WAS FORWARDED TO THE FREMONT FAILURE ANALYSIS LAB FOR PHYSICAL INSPECTION. THE FLUORO SAVER MARKERS WERE SEEN OUT OF POSITION. THE MARKER THAT APPEARED TO BE GREATER IN LENGTH WAS SEEN TO BE COMPRISED OF TWO MARKERS WITH NO GAP BETWEEN THEM. THE DISTAL END OF THE STRAIN RELIEF (PROXIMAL HUB) TO THE DISTAL END OF THE MOST DISTAL MARKER WAS WITHIN SPECIFICATION. THE FIRST THREE PROXIMAL GAPS WERE OUT OF SPECIFICATION. ALL MARKERS WERE WITHIN LENGTH SPECIFICATION. IN THE AREA WHERE THE SECOND AND THIRD MARKERS MEET, THE DISTAL END OF THE SECOND MARKER APPEARS TO HAVE BEEN PEELED BACK PROXIMALLY, INDICATING THAT SOME FORCE WAS ACTING UPON IT. THE DISTAL ENDS OF THE 5TH AND 3RD MARKER ALSO SHOWED SLIGHT INDICATIONS OF BEING COMPRESSED PROXIMALLY. MARKER 2 AND THE DEVICE POSITIONING UNIT (DPU) PROXIMAL TO THE MARKERS WERE SEEN TEXTURED INDICATING THAT FORCES WERE ACTING UPON THEM. THE FORCES IN QUESTION MAY HAVE BEEN CAUSED BY REGULAR HANDLING OF THE PRODUCT AS IT WAS INSERTED INTO THE DELIVERY SYSTEM SINCE THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT UNIT. THE MARKER AND DPU DAMAGE MAY BE UNRELATED TO THE POSITION OF THE MARKERS AS THERE IS NO CLEAR EVIDENCE OF ONE CAUSING THE OTHER. THE IFU INSTRUCTS THE USER TO AVOID OVERTIGHTENING THE ROTATING HEMOSTATIC VALVE (RHV) AS IT MAY CAUSE DAMAGE TO THE DEVICE. OVERTIGHTENING OF THE RHV HAVE CAUSED THE COMPRESSION DAMAGE SEEN AT THE DISTAL END OF THE MARKERS, AS RESISTANCE AGAINST THE RHV MAY HAVE PRESSED THEM BACK PROXIMALLY. THE DEVICE POSITIONING UNIT (DPU) CORE WIRE WAS KINKED AT APPROXIMATELY 62 CM AND 84 CM FROM THE PROXIMAL END OF THE DEVICE. THE DEVICE WAS RETURNED WITH NO EMBOLIC COIL. THE EMBOLIC COIL HAD BEEN DETACHED FROM THE DPU. THE ARTICULATING JOINT AND DISTAL END OF THE DPU WIRE WAS RETURNED UNSHEATHED. THE GREEN INTRODUCER HAD BEEN BROUGHT NEAR TO THE DISTAL END OF THE RESHEATHING TOOL. IT IS RECOMMENDED THAT AT LEAST 2-3 CM OF LENGTH BE KEPT BETWEEN THE RESHEATHING TOOL AND THE GREEN SECTION OF THE INTRODUCER. THE DEVICE WAS THEN INSPECTED MICROSCOPICALLY. THE DISTAL OUTER SHEATH WAS SEEN SOFTENED INDICATING THAT THE DETACHMENT PROCESS WAS INITIATED BY THE DETACHMENT CONTROL BOX. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT REGARDING THE FLUORO SAVER MARKERS. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. AFTER FAILURE ANALYSIS WAS COMPLETED IN THE PRODUCT ANALYSIS LAB IN FREMONT, THE COMPLAINT UNIT WAS SENT TO AN R&D ENGINEERING TEAM AT THE BLUE LAGOON, FLORIDA SITE FOR CONTINUED MICROSCOPIC ANALYSIS. THE IMAGES TAKEN IN BLUE LAGOON CONFIRMED THE MEASUREMENTS AND FINDINGS IN THE FREMONT PRODUCT ANALYSIS LAB. MARKERS 1, 4 AND 5 APPEARED TO BE IN CORRECT POSITION. MARKER 2 WAS OUT OF POSITION DISTALLY AND MARKER 3 WAS OUT OF POSITION PROXIMALLY. THE MARKERS DID NOT APPEAR TO HAVE BEEN MOVED POST SHRINKAGE DURING MANUFACTURING AS THEY WERE NOT LOOSE AND DID NOT HAVE WRINKLES THAT WOULD INDICATE THEY WERE FORCED TO MOVE. THE COMPLAINT OF THE MISSING MARKER BAND WAS NOT CONFIRMED. ALL MARKERS WERE SEEN ON THE DPU; HOWEVER, MARKER 2 AND 3 HAD BEEN POSITIONED SO THAT THERE WAS NO GAP BETWEEN THEM, GIVING THE ILLUSION THAT IT WAS ONE MARKER. MARKERS 2 AND 3 APPEARED TO BOTH HAVE BEEN MOVED TOWARDS EACH OTHER BECAUSE THERE WAS NO GAP BETWEEN THEM AND THE GAPS SURROUNDING THEM WERE OBSERVED TO BE GREATER THAN SPECIFIED LENGTH. THE GAP BETWEEN THE FOURTH AND FIFTH PROXIMAL MARKERS WERE WITHIN SPECIFICATION AND ALL MARKER LENGTHS WERE IN SPECIFICATION, WHICH INDICATES IT IS LIKELY THAT MARKERS 2 AND 3 WERE DISPLACED. NO FLUORO SAVER MARKER WAS LOOSE WHEN ATTEMPTS WERE MADE TO REPOSITION THEM MANUALLY. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED. NO CLEAR OBJECTIVE EVIDENCE COULD BE FOUND TO CONFIRM THAT EITHER HUMAN ERROR DURING MANUFACTURING OR DAMAGE DURING USE IN THE FIELD CONTRIBUTED TO THE MISPLACED MARKER BANDS. THERE IS 100% INSPECTION OF THE FLUORO SAVER MARKERS PERFORMED IN-PROCESS AT THE MANUFACTURING FACILITY. A NON-CONFORMANCE WAS CREATED TO INVESTIGATE THE FLUORO MARKER POSITIONING ISSUE. 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). 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 UNKNOWN. THE PRODUCT WAS RECEIVED BY CERENOVUS FAILURE ANALYSIS LAB ON 11/2/2018, AND IT IS PENDING EVALUATION; WHEN THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IMAGES OF THE COMPLAINT DEVICE WERE RECEIVED FROM THE AFFILIATE. IT APPEARS THAT THE SECOND AND THIRD MOST PROXIMAL MARKERS ARE CONNECTED WITH NO GAP BETWEEN THEM. THE GAPS BETWEEN THE FIRST / SECOND MARKERS AND THIRD / FOURTH MARKERS ARE LARGER THAN THE GAP BETWEEN THE FOURTH AND FIFTH MOST PROXIMAL MARKERS. FURTHER ANALYSIS OF THE RETURNED PRODUCT AT THE FAILURE ANALYSIS LAB IS PENDING. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L12525) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT REGARDING THE FLUORO SAVER MARKERS. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. 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 PROCEDURE, WHEN THE PHYSICIAN OPENED THE PACKAGE TO THE GALAXY G3 XSFT 3MM X 4CM COIL (GLX120304 / L12525), HE NOTICED THAT THE DEVICE HAD A MISSING "FLOURO" SAVER MARKER. THERE WERE SUPPOSED TO BE FIVE (5) FLUORO SAVER MARKERS ON THE DEVICE, BUT ON THIS GALAXY G3 XSFT 3MM X 4CM COIL, THERE WERE ONLY 4 MARKERS. THE ISSUE WAS NOTICED BEFORE THE DEVICE WAS INSERTED INTO THE PATIENT¿S BODY. THE PHYSICIAN MADE THE DECISION TO USE THE COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TOTAL OF FIVE (5) SPECTRA COILS IMPLANTED IN THE "PATIENTS". IT WAS CONFIRMED THAT THERE WERE NO ANOMALIES WITH THE OTHER FOUR (4) COILS; THEY ALL HAVE THE COMPLETE NUMBER OF FLUORO SAVER MARKERS ON THEM. THE PROCEDURE WAS SUCCESSFULLY 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 PRODUCT IS AVAILABLE TO BE RETURNED FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 895877 | GALAXY G3 XSFT 3MM X 4CM | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | SEE H.10 | L12525 | 10886704077688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |