EMBOTRAP II 5X33 REVASC. DEV.
Report
- Report Number
- 3011370111-2019-00117
- Event Type
- Malfunction
- Date Received
- February 20, 2019
- Date of Event
- November 30, 2018
- Report Date
- November 30, 2018
- Manufacturer
- NEURAVI LIMITED
- Product Code
- NRY
- PMA / PMN Number
- K173452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT COMPLAINT #(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO CORRECT THE MANUFACTURER INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT # (B)(4). BASED ON THE PRODUCT INVESTIGATION COMPLETED ON 30-JAN-2019, THE EVENT MEETS THE REQUIRED CRITERIA FOR MDR REPORTING AS A "MALFUNCTION". INFORMATION REGARDING PATIENT AGE/DATE OF BIRTH, GENDER, WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. (B)(6). [COMPLAINT CONCLUSION]: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY PROCEDURE, THE 5X33 EMBOTRAP II (ET007533/18E184AV) REVASCULARIZATION DEVICE COULD NOT BE ADVANCED FROM THE INSERTION TOOL INTO THE REBAR 18 (MEDTRONIC) REINFORCED MICROCATHETER. UPON REMOVAL, A KINK WAS DETECTED AT THE ATTACHMENT POINT BETWEEN THE WIRE AND DEVICE. THE EMBOTRAP II WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED ISSUE. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT PACKAGING DID NOT APPEAR DAMAGED. THE INTEGRITY OF THE INNER STERILE POUCH WAS NOT COMPROMISED. AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE USER DID NOT APPLY UNDUE FORCE AT ANY TIME. NO FURTHER INFORMATION COULD BE OBTAINED. THE 5X33 EMBOTRAP II DEVICE WAS RETURNED FOR EVALUATION. UPON RECEIPT OF THE COMPLAINT DEVICE, VISUAL INSPECTION WAS CONDUCTED. THE INITIAL EXAMINATION OF THE DEVICE IDENTIFIED DEFORMATION OF THE PROXIMAL STRUTS (OUTER CAGE AND INNER CHANNEL) AND CONFIRMED DEFORMATION OF THE STRUTS OF MULTIPLE FLOATING CROWN SEGMENTS. THERE WAS NO EVIDENCE OF ANY STRUT FRACTURES. THE VISUAL INSPECTION ALSO REVEALED THAT THE DEVICE WAS CORRECTLY ASSEMBLED AND MANUFACTURED, WITH ALL ADHESIVE BONDS AND JOINTS COMPLETE AND UNDAMAGED. THE DAMAGE NOTED DURING THE VISUAL INSPECTION UNDER MAGNIFICATION IS INDICATIVE OF EXCESSIVE PUSHING OF THE DEVICE AGAINST RESISTANCE WHILE IN A PARTIALLY EXPANDED STATE. THE DEVICE WAS SUCCESSFULLY PASSED THROUGH A 0.0195¿ TUBE, CONFIRMING THAT THE PROFILE CONFORMED TO THE SPECIFICATION FOR COMPATIBILITY WITH 0.021¿ MICROCATHETERS. THE PTFE INSERTION TOOL WAS DIMENSIONALLY INSPECTED AND FOUND TO BE WITHIN SPECIFICATION FOR THE OUTER DIAMETER (OD). THE EMBOTRAP, LOADED INTO INSERTION TOOL, WAS INSERTED INTO A LAB SAMPLE REBAR 18 (MEDTRONIC, LOT NO. A062463) MICROCATHETER, WITH ONE PREVIOUS USE AND WITH A STANDARD ROTATING HEMOSTASIS VALVE (RHV) ATTACHED. THE EMBOTRAP WAS THEN ADVANCED INTO THE REBAR 18 MICROCATHETER WITH THE DISTAL END OF THE INSERTION TOOL LOCATED AT VARIOUS LOCATIONS RELATIVE TO THE LUMEN OF THE MICROCATHETER (5MM, 8MM, & 10MM). THE DISTANCE IS THE DISTANCE FROM THE DISTAL END OF THE INSERTION TOOL TO THE LUMEN AT THE PROXIMAL END OF THE MICROCATHETER SHAFT. THE RHV SEAL WAS THEN TIGHTENED AND THE EMBOTRAP DEVICE WAS ADVANCED FORWARD INTO THE LUMEN OF THE MICROCATHETER AND DELIVERED THROUGH THE ENTIRE MICROCATHETER LENGTH AND THEN RETRACTED. THE INSERTION AND DELIVERY OF THE DEVICE WAS SUCCESSFUL WHEN THE INSERTION TOOL WAS PUSHED FULLY FORWARD (APPROXIMATELY 5MM GAP BETWEEN DISTAL END OF INSERTION TOOL AND PROXIMAL LUMEN OF MICROCATHETER) INTO THE REBAR 18 MICROCATHETER. THE EMBOTRAP WAS ALSO SUCCESSFULLY INSERTED AND DELIVERED WITH A GAP OF 8MM. WHEN THE GAP BETWEEN DISTAL END OF INSERTION TOOL AND PROXIMAL LUMEN OF MICROCATHETER WAS INCREASED TO 10MM, THE INSERTION OF THE EMBOTRAP WAS UNSUCCESSFUL. THE DELIVERY FORCE INCREASED, AND THE PROXIMAL SECTION OF THE DEVICE KINKED JUST DISTAL OF THE PROXIMAL COLLAR OF THE OUTER CAGE. THE LOCATION OF THE KINK WAS CONSISTENT WITH THE DAMAGE NOTED DURING VISUAL INSPECTION UNDER MAGNIFICATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE HISTORY RECORDS INDICATE THIS PRODUCT CONFORMED TO MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE CUSTOMER REPORT THAT THE DEVICE WAS KINKED/BENT WAS CONFIRMED DURING VISUAL INSPECTION. THE CUSTOMER REPORT THAT THE DEVICE WAS IMPEDED IN THE MICROCATHETER WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. DEVICE INSERTION AND DELIVERY ASSESSMENTS WERE PERFORMED USING THE RETURNED EMBOTRAP II DEVICE AND A LAB SAMPLE REBAR 18 (MEDTRONIC) MICROCATHETER. THE RETURNED DEVICE WAS ADVANCED FROM THE INSERTION TOOL INTO THE LUMEN OF THE REBAR 18 MICROCATHETER WITH NO NOTED RESISTANCE AND SUCCESSFULLY ADVANCED FORWARD THROUGH THE ENTIRE LENGTH OF THE MICROCATHETER. THIS WAS CONFIRMED WITH THE INSERTION TOOL FULLY SEATED IN THE MICROCATHETER HUB AND ALSO WITH GAPS (I.E. DISTANCE FROM THE DISTAL END OF THE INSERTION TOOL TO THE LUMEN AT THE PROXIMAL END OF THE MICROCATHETER SHAFT) OF UP TO 8MM. ADVANCEMENT WAS UNSUCCESSFUL AT A GAP GREATER THAN 8MM (I.E. INCORRECTLY SEATED). THE EVENT DESCRIPTION STATES THAT A NEW EMBOTRAP DEVICE WAS SUCCESSFULLY PASSED THROUGH THE SAME MICROCATHETER BY THE PHYSICIAN AFTER THE INITIAL FAILURE TO DELIVER THE OFFENDING EMBOTRAP DEVICE, INDICATING THAT THE PHYSICIAN IS AWARE OF CORRECTLY SEATING THE PTFE INSERTION TOOL IN THE MICROCATHETER HUB PRIOR TO DEVICE DELIVERY AND IT IS UNLIKELY THAT A PERMANENT CONSTRUCTION OR OCCLUSION EXISTED IN THE MICROCATHETER HUB. THE RETURNED EMBOTRAP DEVICE EXHIBITS KEY CHARACTERISTICS WHICH ARE CONSISTENT WITH ATTEMPTED DELIVERY INTO A MICROCATHETER AGAINST SIGNIFICANT RESISTANCE. IMPEDED IN MICROCATHETER AND DEVICE DAMAGE ARE KNOWN POTENTIAL FAILURES ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: ¿INSERT THE DISTAL END OF THE INSERTION TOOL THROUGH THE RHV OF THE MICROCATHETER AND WAIT UNTIL FLUID IS SEEN EXITING THE PROXIMAL END OF THE INSERTION TOOL, CONFIRMING THAT THE DEVICE IS FLUSHED. ADVANCE THE INSERTION TOOL UNTIL IT IS FULLY SEATED IN THE HUB OF THE MICROCATHETER. FULLY TIGHTEN THE RHV TO HOLD THE INSERTION TOOL SECURELY IN POSITION. CONFIRM THAT THE INSERTION TOOL IS FULLY SEATED IN THE HUB OF THE RHV BEFORE PROCEEDING TO ADVANCE THE DEVICE. ADVANCE THE DEVICE UNTIL AT LEAST HALF OF THE SHAFT LENGTH HAS BEEN INSERTED INTO THE MICROCATHETER, AT WHICH POINT THE INSERTION TOOL MAY BE REMOVED.¿ THE IFU ALSO CAUTIONS: ¿DO NOT USE DAMAGED OR KINKED DEVICES. DO NOT ADVANCE THE DEVICE THROUGH THE MICROCATHETER AGAINST SIGNIFICANT RESISTANCE.¿ ALTHOUGH A VISUAL EXAMINATION OF THE CONCOMITANT MICROCATHETER USED DURING THIS COMPLAINT WAS NOT POSSIBLE AS THE MICROCATHETER WAS NOT RETURNED FOR INVESTIGATION, THE SUCCESSFUL DELIVERY/ DEPLOYMENT OF THE DEVICE THROUGH A REBAR 18 MICROCATHETER DURING EVALUATION OF THE RETURNED EMBOTRAP DEVICE INDICATES THAT THE MOST PROBABLE ROOT CAUSE(S) WOULD BE THAT EITHER A LOCALIZED, TEMPORARY CONSTRICTION IN THE PROXIMAL END OF THE MICROCATHETER EXISTED THAT PREVENTED DELIVERY OF THE RETURNED EMBOTRAP DEVICE (I.E. SUCH AS A KINK OR CONSTRICTION IN THE LUMEN POTENTIALLY DUE TO EXCESSIVE ANGULATION OF THE PROXIMAL END OF THE MICROCATHETER) OR THE RHV SEAL WAS NOT FULLY TIGHTENED THEREBY ALLOWING SOME SLIPPAGE OF THE INSERTION TOOL IN THE RHV DURING DEVICE DELIVERY. THERE IS NO INDICATION THAT THIS COMPLAINT WAS AS A RESULT OF A DEFECT WITH THE EMBOTRAP DEVICE. 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.
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY PROCEDURE, THE 5X33 EMBOTRAP II (ET007533/18E184AV) REVASCULARIZATION DEVICE COULD NOT BE ADVANCED FROM THE INSERTION TOOL INTO THE REBAR 18 (MEDTRONIC) REINFORCED MICROCATHETER. UPON REMOVAL, A KINK WAS DETECTED AT THE ATTACHMENT POINT BETWEEN THE WIRE AND DEVICE. THE EMBOTRAP II WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED ISSUE. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT PACKAGING DID NOT APPEAR DAMAGED. THE INTEGRITY OF THE INNER STERILE POUCH WAS NOT COMPROMISED. AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE USER DID NOT APPLY UNDUE FORCE AT ANY TIME. PRELIMINARY EVALUATION OF THE RETURNED DEVICE REVEALED DEFORMATION OF THE PROXIMAL STRUTS (OUTER CAGE AND INNER CHANNEL) AND CONFIRMED DEFORMATION OF THE STRUTS OF MULTIPLE FLOATING CROWN SEGMENTS. NO FURTHER INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146905 | EMBOTRAP II 5X33 REVASC. DEV. | CATHETER, THROMBUS RETRIEVER | NRY | NEURAVI LIMITED | 18E184AV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | REBAR 18 (MEDTRONIC) MC |