EMBOTRAP II 5X33 REVASC. DEV.
Report
- Report Number
- 3011370111-2019-00160
- Event Type
- Malfunction
- Date Received
- October 29, 2019
- Date of Event
- October 2, 2019
- Report Date
- October 11, 2019
- Manufacturer
- NEURAVI LTD.
- Product Code
- NRY
- PMA / PMN Number
- K173452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (B)(4). MANUFACTURER SITE POSTAL CODE: H91 PV0V. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
PRODUCT COMPLAINT # (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY PROCEDURE, A 5X33 EMBOTRAP II STENT RETRIEVER (ET007533, 19G123AV) BECAME ¿STUCK¿ INTO THE 021 PROWLER SELECT MICROCATHETER (6062510, 30187162). THE DEVICE WAS NOT ABLE TO MOVE WITHIN THE MICROCATHETER. DUE TO THE RESISTANCE, THE MICROCATHETER WAS REMOVED AND THERE WAS LOSS OF CEREBRAL TARGET POSITION. THE DEVICES WERE FLUSHED WITHOUT DIFFICULTIES BEFORE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT NOR CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS COMPLETED BY THE PHYSICIAN USING ANOTHER SET OF DEVICES. THE EMBOTRAP NOR THE PROWLER SELECT APPEARED DAMAGED. THE INSERTION TOOL WAS SECURELY PLACED IN THE HUB OF THE MICROCATHETER PRIOR TO ATTEMPTING TO ADVANCE THE EMBOTRAP. THE TECHNIQUE USED TO HOLD THE INSERTION TOOL IN POSITION DURING ADVANCEMENT OF THE DEVICE WAS CORRECT. THE DEVICE WAS ABLE TO ADVANCE THROUGH THE HUB. ONE PASS HAD BEEN ATTEMPTED TO RETRIEVE THE CLOT. THE INITIAL EXAMINATION OF THE RETURN EMBOTRAP DEVICE IDENTIFIED THAT IT WAS STUCK IN THE DISTAL END OF THE RETURNED PROWLER SELECT PLUS MICROCATHETER. THE RETURNED EMBOTRAP WAS PARTIALLY SHEATHED IN THE MICROCATHETER AND THERE WAS CONGEALED BLOOD AROUND BOTH DEVICES AND FLAT SPOTS WERE IDENTIFIED ON THE DISTAL END OF THE MICROCATHETER. THE DEVICE WOULD BE DELIVERABLE THROUGH THESE FLAT SPOTS HOWEVER ONCE THE DEVICE SHAFT IS PRESENT THE CONTINUOUS FLUSH MAY NOT BE POSSIBLE. USING A HIGH FORCE, THE DEVICE WAS EVENTUALLY REMOVED FROM THE MICROCATHETER. UNFORTUNATELY, THE MICROCATHETER WAS EXCESSIVELY DAMAGED DURING REMOVAL OF THE DEVICE THAT NO FURTHER INVESTIGATION COULD BE COMPLETED INTO THE MICROCATHETER. ONCE REMOVED THERE WAS NO EVIDENCE OF DEFORMATION OR STRUT FRACTURES ON THE EMBOTRAP DEVICE. THE VISUAL INSPECTION ALSO INDICATES THAT THE RETURN EMBOTRAP DEVICE WAS CORRECTLY ASSEMBLED AND MANUFACTURED, WITH ALL ADHESIVE BONDS AND JOINTS COMPLETE AND UNDAMAGED. THE RETURN EMBOTRAP DEVICE WAS SUCCESSFULLY PASSED THROUGH A 0.0195¿ TUBE, CONFIRMING THAT THE PROFILE CONFORMED TO THE SPECIFICATION FOR COMPATIBILITY WITH 0.021¿ MICROCATHETERS. DEVICE INSERTION AND DELIVERY ASSESSMENTS WERE PERFORMED USING THE RETURN EMBOTRAP DEVICE AND A SAMPLE PROWLER SELECT PLUS MICROCATHETER. THE RETURNED DEVICE WAS ADVANCED FROM THE INSERTION TOOL INTO THE LUMEN OF THE PROWLER SELECT PLUS MICROCATHETER WITH NO NOTED RESISTANCE AND SUCCESSFULLY ADVANCED FORWARD THROUGH THE ENTIRE LENGTH OF THE MICROCATHETER, RE-SHEATHED, REDEPLOYED AND THEN REMOVED SUCCESSFULLY. THIS WAS CONFIRMED WITH THE INSERTION TOOL FULLY SEATED IN THE MICROCATHETER HUB INDICATING THE DEVICE WAS NOT DAMAGED DESPITE BEING STUCK IN THE MICROCATHETER AND THE HIGH FORCE IT TOOK TO REMOVE THE DEVICE. IT IS CONCLUDED THAT THE DEVICE IS UNDAMAGED AND FUNCTIONING CORRECTLY. THE EMBOTRAP II 5X33MM DEVICE WAS RETURNED DUE TO THE DEVICE BEING STUCK IN THE DISTAL END OF THE MICROCATHETER. THIS COULD HAVE HAPPENED UPON REPOSITIONING OF THE DEVICE OR UPON RETRIEVAL OF THE DEVICE. THE MOST PROBABLE CAUSES OF THE FAILURE TO ADVANCE THROUGH THE MICROCATHETER ARE: THE MICROCATHETER COULD HAVE BEEN DAMAGED PRIOR TO USE AS FLAT SPOTS WERE IDENTIFIED ALONG THE DISTAL END OF THE CATHETER MAKING IT DIFFICULT TO RETRIEVE/REPOSITION THE EMBOTRAP DEVICE DURING INITIAL INSPECTION BY RESTRICTING THE LUMEN. THIS CONSTRICTION COULD ALSO STOP THE CONTINUOUS FLUSH OF THE MICROCATHETER WHICH WOULD ALLOW BLOOD TO CLOT AT THE DISTAL END OF THE MICROCATHETER AND ON THE DEVICE WHICH MAKE IT VERY DIFFICULT TO WITHDRAW THE DEVICE. DURING DECONTAMINATION A SIGNIFICANT AMOUNT OF CLOT WAS IDENTIFIED AS COMING OFF THE COMBINATION OF DEVICES DURING THE ATTEMPTS TO REMOVE THE DEVICE FROM THE MICROCATHETER. THIS CLOT COULD HAVE BEEN STUCK IN THE DISTAL END OF THE MICROCATHETER OR IN THE DEVICE MAKING IT DIFFICULT TO REMOVE/REPOSITION THE DEVICE WHICH CAUSED THE DEVICE TO GET STUCK IN THE MICROCATHETER DUE TO THE CONSTRICTION IN THE DISTAL END AND THE LACK OF FLUSH. THE MOST PROBABLE ROOT CAUSE(S) WOULD BE THAT THE MICROCATHETER WAS DAMAGED BEFORE USE AND THE PHYSICIAN ATTEMPTED TO REMOVE/REPOSITION THE DEVICE WHEN THERE WAS SOME BLOOD CLOTTING AT DISTAL END OF THE DEVICE WHICH MEANT THE DEVICE COULD NOT CRIMP DOWN FULLY CAUSING THE DEVICE TO GET STUCK IN THE DISTAL END OF THE MICROCATHETER AS THERE WAS NO FLUSH DUE TO THE CONSTRICTION (FLAT SPOTS) IN THE DISTAL END OF THE MICROCATHETER. 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 EVENT. THE REPORTED CUSTOMER COMPLAINT OF ¿EMBOTRAP - IMPEDED IN MC WITH LOSS OF CEREBRAL TARGET POSITION¿ COULD NOT BE CONFIRMED. THE SUCCESSFUL DELIVERY/ DEPLOYMENT OF THE DEVICE THROUGH A PREVIOUSLY UNUSED PROWLER SELECT PLUS MICROCATHETER DURING EVALUATION OF THE RETURNED EMBOTRAP PRODUCT INDICATES THAT THE MOST PROBABLE ROOT CAUSE(S) WOULD BE THAT THE MICROCATHETER WAS DAMAGED PRIOR TO USE AND THIS CONSTRICTION PREVENTED CATHETER IRRIGATION LEADING TO BLOOD CLOTTING AT THE DISTAL END MAKING IT VERY DIFFICULT TO REMOVE THE DEVICE. THERE IS NO INDICATION THAT THIS COMPLAINT WAS AS A RESULT OF A DEFECT WITH THE EMBOTRAP DEVICE. THE INSTRUCTIONS FOR USE OF THE EMBPTRAP (IFU) WARNS TO NOT ADVANCE THE DEVICE THROUGH THE MICROCATHETER AGAINST SIGNIFICANT RESISTANCE. 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. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION PROVIDED. HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008264254-2019-00564 AND 3011370111-2019-00160.
PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. EXPIRATION DATE ¿ NOT AVAILABLE AT THE TIME OF THE REPORT. INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. DEVICE MANUFACTURE DATE: - NOT AVAILABLE AT THE TIME OF THE REPORT. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3011370111-2019-00160 AND 3008264254-2019-00564.
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A MECHANICAL THROMBECTOMY PROCEDURE, A 5X33 EMBOTRAP II STENT RETRIEVER (ET007533, 19G123AV) BECAME ¿STUCK¿ INTO THE 021 PROWLER SELECT MICROCATHETER (6062510, 30187162). THE DEVICE WAS NOT ABLE TO MOVE WITHIN THE MICROCATHETER. DUE TO THE RESISTANCE, THE MICROCATHETER WAS REMOVED AND THERE WAS LOSS OF CEREBRAL TARGET POSITION. THE DEVICES WERE FLUSHED WITHOUT DIFFICULTIES BEFORE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT NOR CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS COMPLETED BY THE PHYSICIAN USING ANOTHER SET OF DEVICES. THE EMBOTRAP NOR THE PROWLER SELECT APPEARED DAMAGED. THE INSERTION TOOL WAS SECURELY PLACED IN THE HUB OF THE MICROCATHETER PRIOR TO ATTEMPTING TO ADVANCE THE EMBOTRAP. THE TECHNIQUE USED TO HOLD THE INSERTION TOOL IN POSITION DURING ADVANCEMENT OF THE DEVICE WAS CORRECT. THE DEVICE WAS ABLE TO ADVANCE THROUGH THE HUB. ONE PASS HAD BEEN ATTEMPTED TO RETRIEVE THE CLOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1045574 | EMBOTRAP II 5X33 REVASC. DEV. | EMBOTRAP II | NRY | NEURAVI LTD. | 19G123AV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PROWLER + 6062510X 150X20 DMB |