EMBOTRAP II 5X33 REVASC. DEV.
Report
- Report Number
- 3011370111-2018-00104
- Event Type
- Malfunction
- Date Received
- September 18, 2018
- Date of Event
- August 8, 2018
- Report Date
- August 29, 2018
- Manufacturer
- NEURAVI LIMITED
- Product Code
- NRY
- PMA / PMN Number
- K173452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
MANUFACTURER¿S REF. NO: (B)(4). [CONCLUSION]: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A THROMBECTOMY OF AN OCCLUSION IN THE RIGHT MIDDLE CEREBRAL ARTERY (M1 SEGMENT), THE 5 X 33 EMBOTRAP II (ET007533/17L040AV) THROMBECTOMY DEVICE WAS DEPLOYED WITHOUT DIFFICULTY BUT BECAME STUCK IN THE SOFIA PLUS 131CM (MICROVENTION) INTERMEDIATE CATHETER DURING THE FIRST RETRIEVAL ATTEMPT. THE PHYSICIAN REMOVED A SMALL PORTION OF THE CLOT ON THE FIRST ATTEMPT BUT DUE TO THE ISSUE RELATED TO THE FIRST RETRIEVAL, THE SYSTEM WAS REMOVED FROM THE PATIENT VASCULATURE AND A COMPETITOR DEVICE WAS USED TO RETRIEVE THE REMAINDER OF THE CLOT. THE PHYSICIAN WAS ABLE TO REMOVE THE EMBOTRAP II FROM THE CATHETER OUTSIDE OF THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PATIENT¿S PRE-PROCEDURE TICI SCORE WAS 1 AND POST-PROCEDURE SCORE WAS 2A. THE SOURCE OF THE RESISTANCE DURING REMOVAL OF THE EMBOTRAP COULD NOT BE IDENTIFIED. THE PRODUCTS DID NOT APPEAR DAMAGED IN ANY WAY. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE EMBOTRAP. THE PRODUCT WAS PREPPED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED. EXCESSIVE FORCE WAS NOT APPLIED AT ANY TIME. IT IS NOT KNOWN IF THERE WAS EVIDENCE OF DISTAL EMBOLIZATION. THE SURGERY WAS DELAYED 20 MINUTES DUE TO THE EVENT. THE VESSEL WAS REPORTEDLY ¿QUITE¿ TORTUOUS, BUT THERE WAS NO VISUAL CALCIFICATION. A 6F SHUTTLE (COOK MEDICAL) SHEATH AND A REBAR-027 (MEDTRONIC) MICROCATHETER WERE ALSO USED FOR THE CASE. THE SOFIA CATHETER WAS DISCARDED BY THE CUSTOMER AND IS THUS NOT AVAILABLE FOR RETURN. THE EMBOTRAP DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT. INVESTIGATION SUMMARY: THE 5 X 33 EMBOTRAP II WAS RECEIVED FOR INVESTIGATION. ANCILLARY DEVICES WERE NOT RETURNED. UPON INITIAL INSPECTION, IT WAS EVIDENT OF THE OUTER CAGE AND INNER CHANNEL COMPONENTS ENTANGLEMENT. CLOSER INSPECTION INDICATED THAT ONE OF THE FLOATING CROWNS OF THE FIRST SEGMENT OF THE OUTER CAGE WAS ENTANGLED WITHIN A CELL OF THE INNER CHANNEL. THE DEVICE WAS UNTANGLED AFTER DISINFECTION / DECONTAMINATION. KINKING WAS OBSERVED ON THE OUTER CAGE, BUT THIS WAS MOST LIKELY DUE TO THE ENTANGLEMENT AS IT WAS ON THE SAME FLOATING CROWN. INVESTIGATION CONCLUSION: IT IS CONCLUDED THAT THE ROOT CAUSE WAS DUE TO THE DEVICE BEING DEPLOYED WHILE IT WAS BEING ADVANCED EITHER IN A VESSEL OR IN THE SOFIA PLUS INTERMEDIATE CATHETER. THIS CONCLUSION IS SUPPORTED BY THE REPLICATION OF PROXIMAL MOVEMENT ON A DEPLOYED DEVICE ON THE LAB BENCH, WHICH RESULTED IN THE SAME ENTANGLEMENT THAT WAS OBSERVED ON THE COMPLAINT DEVICE. THIS CONTRADICTS WITH WARNING AND PRECAUTIONS IN THE INSTRUCTION FOR USE (IFU), WHICH STATES: DO NOT ADVANCE THE DEVICE AFTER IT HAS BEEN DEPLOYED OR PARTIALLY DEPLOYED FROM THE MICROCATHETER. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THIS COMPLAINT WAS A RESULT OF A DEFECT WITH THE EMBOTRAP DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT: (17L040AV) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PROCEDURAL FACTORS AND/OR DEVICE MANIPULATION / INTERACTION MOST LIKELY CONTRIBUTED TO THE REPORTED ISSUE RELATED TO THE RETRIEVAL OF THE EMBOTRAP DEVICE INTO THE SOFIA PLUS INTERMEDIATE CATHETER AFTER DEPLOYMENT. THE IFU STATES WARNING AND PRECAUTIONS AGAINST ADVANCING THE DEVICE AFTER IT HAS BEEN DEPLOYED OR PARTIALLY DEPLOYED FROM THE MICROCATHETER. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PRODUCT LOT NUMBER WAS 17L040AV. THE EVENT OCCURRED DURING THE FIRST RETRIEVAL ATTEMPT. THE EMBOTRAP WAS DEPLOYED WITHOUT DIFFICULTY, BUT THE PRODUCT BECAME STUCK IN THE SOFIA PLUS CATHETER DURING WITHDRAWAL. ACCORDING TO THE PHYSICIAN, A SMALL PORTION OF THE CLOT WAS REMOVED ON THE FIRST ATTEMPT, BUT THE WITHDRAWAL ISSUE OCCURRED, AND A COMPETITOR DEVICE HAD TO BE USED TO RETRIEVE THE REMAINDER OF THE CLOT. THE PATIENT¿S PRE-PROCEDURE TICI SCORE WAS 1 AND POST-PROCEDURE SCORE WAS 2A. THE SOURCE OF THE RESISTANCE DURING REMOVAL OF THE EMBOTRAP COULD NOT BE IDENTIFIED. THE PRODUCTS DID NOT APPEAR DAMAGED IN ANY WAY. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE EMBOTRAP. THE PRODUCT WAS PREPPED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED. EXCESSIVE FORCE WAS NOT APPLIED AT ANY TIME. IT IS NOT KNOWN IF THERE WAS EVIDENCE OF DISTAL EMBOLIZATION. THE SURGERY WAS DELAYED 20 MINUTES DUE TO THE EVENT. THE VESSEL WAS REPORTEDLY ¿QUITE¿ TORTUOUS, BUT THERE WAS NO VISUAL CALCIFICATION. THE SOFIA CATHETER WAS DISCARDED BY THE CUSTOMER AND IS THUS NOT AVAILABLE FOR RETURN. INITIAL REPORTER PHONE: (B)(6). THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
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.
(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT # (B)(4). (B)(6). THE STERILE LOT NUMBER WAS NOT REPORTED. CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: SOFIA PLUS 131CM (MICROVENTION) INTERMEDIATE CATHETER, SHUTTLE 6F SHEATH, REBAR-027 (MEDTRONIC) MICROCATHETER. INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING OCCUPATION, PHONE, AND FAX, WAS NOT REPORTED. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE (WHICH IS INDICATED AS "OTHER" IN SECTION). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. 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.
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A THROMBECTOMY OF AN OCCLUSION IN THE RIGHT MIDDLE CEREBRAL ARTERY (M1 SEGMENT), THE 5 X 33 EMBOTRAP II (ET007533/UNK LOT) THROMBECTOMY DEVICE BECAME STUCK IN THE SOFIA PLUS 131CM (MICROVENTION) INTERMEDIATE CATHETER DURING RETRIEVAL. THE PHYSICIAN REMOVED THE SYSTEM FROM THE PATIENT VASCULATURE AND THE DEVICES WERE REPLACED. THE PHYSICIAN WAS ABLE TO REMOVE THE EMBOTRAP II FROM THE CATHETER OUTSIDE OF THE PATIENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. A 6F SHUTTLE (COOK MEDICAL) SHEATH AND A REBAR-027 (MEDTRONIC) MICROCATHETER WERE ALSO USED FOR THE CASE. THE PRODUCT WILL BE RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724915 | EMBOTRAP II 5X33 REVASC. DEV. | CATHETER, THROMBUS RETRIEVER | NRY | NEURAVI LIMITED | 17L040AV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |