GALAXY G3 MINI 1.5MM X 3CM
Report
- Report Number
- 3008114965-2024-00426
- Event Type
- Malfunction
- Date Received
- April 24, 2024
- Date of Event
- April 9, 2024
- Report Date
- May 22, 2024
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- KRD
- UDI-DI
- 10886704080145
- PMA / PMN Number
- K171862
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT (B)(4). SECTION B5: ADDITIONAL EVENT INFORMATION RECEIVED ON 26-APR-2024 INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE FAILURE DID NOT OCCUR DURING PRE-DEPLOYMENT ELECTRICAL CHECK. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL BECAME STRETCHED WHEN PULLED FROM COIL MICROCATHETER. THE TARGET VESSEL/SITE WAS THE RIGHT OPHTHALMIC ARTERY ANEURYSM. THE PROCEDURE WAS JUST PROLONGED BY THE TIME IT TAKES TO REPLACE THE COILS, THERE WAS NO CLINICAL SIGNIFICANCE IN THE DELAYS. BASED ON THE ADDITIONAL INFORMATION RECEIVED SECTION H6. MEDICAL DEVICE PROBLEM CODE: STRETCHED (A040611) HAS BEEN ADDED TO THE REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION D2B ¿ PROCODE: KRD/HCG SECTION E1. INITIAL REPORTER PHONE: (B)(6). SECTION H3 - 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. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT (B)(4) COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE FIRST COIL WAS FILLED IN THE ANEURYSM AND WAS DETACHED SUCCESSFULLY, BUT THE SECOND COIL, A GALAXY G3 MINI 1.5MM X 3CM (GLM915030, 30937887) WAS UNABLE TO BE DETACHED. THE PHYSICIAN SWITCHED TO A NEW DETACHMENT BOX AND THEN PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO BE DETACHED. THEN THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO NEW ONE TO COMPLETE THE SURGERY. DURING THE SURGERY, THE PHYSICIAN INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECT CABLE, AND OBSERVED ALL WERE IN GOOD CONDITION. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED DURING THE SURGERY. NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2024 INDICATES THAT THE COIL WAS STRETCHED WHEN PULLED FROM COIL MICROCATHETER. THE PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN WAS REMOVED FROM THE PATIENT. A NON-STERILE GALAXY G3 1.5MM X 3CM WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE COIL WAS INSIDE THE INTRODUCER. NO OTHER DAMAGES WERE FOUND. THE DEVICE WAS INSPECTED UNDER MICROSCOPIC MAGNIFICATION, AND THE EMBOLIC COIL WAS FOUND STILL ATTACHED TO THE RESISTANCE HEATING (RH). THE DISTAL OUTER SHEATH HAD NOT BEEN SOFTENED, INDICATING THAT THE DETACHMENT PROCESS WAS NOT INITIATED. THE COIL WAS NOTED TO HAVE SOME KINKED CONDITIONS ON IT. THE ELECTRICAL RESISTANCE OF THE GALAXY G3 DEVICE WAS MEASURED WITH A MULTIMETER, WHICH IS WITHIN THE SPECIFICATION RANGE. ALSO, THE DEVICE WAS CONNECTED TO A LAB SAMPLE DETACHMENT CONTROL BOX (DCB), AND TO A LAB SAMPLE ENPOWER CONTROL CABLE, AND THE POWER WAS TURNED ON. THE SYSTEM READY LIGHT WAS ILLUMINATING. THEN, THE DETACH BUTTON WAS PRESSED, AND A BEEP SOUND WAS HEARD. THE COIL WAS SUCCESSFULLY DETACHED FROM THE UNIT. THE ISSUE DOCUMENTED THAT THE COIL FAILED TO DETACH COULD NOT BE CONFIRMED SINCE THE DEVICE MET THE ELECTRICAL SPECIFICATION RANGE. ADDITIONALLY, NO PRODUCT DEFECT WAS IDENTIFIED; THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED IN THE LAB SETTING. THE INSTRUCTIONS FOR USE (IFU) PROVIDE PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUES FROM OCCURRING. ACCORDING TO THE RISK DOCUMENTATION, FAILURE TO DETACH IS A POTENTIAL ISSUE THAT CAN OCCUR DURING THE COIL DETACHMENT DUE TO A DETACHMENT CYCLE NOT BEING INITIATED, AS A RESULT OF THE DPU WIRE DETACHMENT ZONE/EXTENDED COIL BEING POSITIONED BEYOND THE MICROCATHETER TIP, WHICH CAN RESULT IN REPORTED FAILURE. THE ISSUE REGARDING A EMBOLIC COIL BEING STRETCHED WAS CONFIRMED BASED ON THE KINKED CONDITIONS OBSERVED ON THE COIL THESE ARE CONSIDERED RELATED TO THE REPORTED ISSUE. COIL KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDE PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUE FROM OCCURRING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30937887 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THEREFORE, NO CAPA ACTIVITY IS REQUIRED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATION: VERIFY THAT THE MICROCOIL DELIVERY SYSTEM IS FULLY CONNECTED, AND NO FAULTS ARE INDICATED ON THE DCB. IF A FAULT EXISTS, RESEAT ALL CONNECTIONS BETWEEN THE DPU, THE DCB, AND THE CONNECTING CABLE. IF A FAULT STILL PERSISTS, REPLACE THE CONNECTING CABLE. IF THIS DOES NOT CORRECT THE ERROR, REPLACE THE DCB. IF THE MICROCOIL DELIVERY SYSTEM STILL CONTINUES TO HAVE A FAULT, RETRIEVE THE MICROCOIL, RE SHEATHING THE MICROCOIL SYSTEM, AND REPLACE IT WITH A NEW MICROCOIL SYSTEM. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE FIRST COIL WAS FILLED IN THE ANEURYSM AND WAS DETACHED SUCCESSFULLY, BUT THE SECOND COIL, A GALAXY G3 MINI 1.5MM X 3CM (GLM915030, 30937887) WAS UNABLE TO BE DETACHED. THE PHYSICIAN SWITCHED TO A NEW DETACHMENT BOX AND THEN PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO BE DETACHED. THEN THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO NEW ONE TO COMPLETE THE SURGERY. DURING THE SURGERY, THE PHYSICIAN INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECT CABLE, AND OBSERVED ALL WERE IN GOOD CONDITION. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED DURING THE SURGERY. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1330168 | GALAXY G3 MINI 1.5MM X 3CM | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | MEDOS INTERNATIONAL SARL | 30937887 | 10886704080145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DETACHMENT CONTROL BOX| MICROCATHETER (UNSPECIFIED BRAND)| UNK CONNECTING CABLE |