132CM EMBOVAC 71 ASP. CATHETER
Report
- Report Number
- 3008114965-2021-00700
- Event Type
- Injury
- Date Received
- December 29, 2021
- Date of Event
- December 5, 2021
- Report Date
- January 13, 2022
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NRY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL IS NOT AVAILABLE / REPORTED. THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE, A 132CM EMBOVAC 71 ASPIRATION CATHETER (IC71132CA / 30557977) WAS USED TO REMOVE THROMBUS, BUT THE DISTAL END OF THE CATHETER BECAME KINKED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET OCCLUSION WAS LOCATED AT THE INTERNAL CAROTID (IC) TOP; THERE WAS ¿MUCH THROMBUS¿. THE FIRST PASS WAS MADE VIA ASPIRATION CATHETER WITH PROXIMAL BALLOON (ASAP) TECHNIQUE. THE EMBOVAC AND A 6MM TRON STENT RETRIEVER (BIOMEDICAL SOLUTIONS, INC.) WERE USED, AND SUCTION WAS PERFORMED WITH VACLOK® VACUUM PRESSURE SYRINGE (MERIT MEDICAL). THE TRON STENT RETRIEVER WAS REMOVED, AND THE EMBOVAC REMAINED AT THE TARGET OCCLUSION. ¿LITTLE¿ THROMBUS WAS REMOVED. ANGIOGRAPHY CONFIRMED THE PRESENCE OF THROMBUS AT THE IC TOP. THEREFORE, A SECOND PASS WAS MADE WITH THE SAME SYSTEM. HOWEVER, BACK-FLOW WAS STILL NOT CONFIRMED. THEREFORE, MANUAL SUCTION WAS PERFORMED, AND THE EMBOVAC AND THE TRON WERE REMOVED AS A UNIT. AFTER REMOVAL, IT WAS CONFIRMED THAT THE EMBOVAC HAD KINKED APPROXIMATELY 15 TO 30 CM FROM THE DISTAL END OF THE DEVICE. THERE WAS ¿MUCH¿ THROMBUS NOTED ON THE DISTAL END. IT WAS CONFIRMED THAT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) WAS OBSTRUCTED. THE PHYSICIAN TRIED TO USE THE COMPLAINT DEVICE, BUT THE TREVO TRAK 21 MICROCATHETER (STRYKER) FAILED TO ADVANCE. THROMBUS WAS REMOVED WITH THE 2MM TRON STENT RETRIEVER (ONLY) AND THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT THE M2 OBSTRUCTION WAS PROBABLY CAUSED BY CLOT MIGRATION/EMBOLIZATION TO NEW TERRITORY (ENT). ON 16-DEC-2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE EMBOVAC AND 6MM TRON WERE USED FOR THE FIRST PASS, BUT THE PHYSICIAN CONFIRMED THAT THE THROMBUS REMAINED AT THE IC-TOP. M2 OCCLUSION WAS NOT NOTED AT THIS TIME. THE SAME SYSTEM WAS USED AGAIN FOR THE SECOND PASS, BUT THE BACK FLOW FROM THE VACLOK SYRINGE WAS NOT CONFIRMED. THUS, MANUAL SUCTION WAS PERFORMED, AND THE DEVICES WERE REMOVED AS A UNIT. THE KINK IN THE EMBOVAC WAS NOTED AT THE TIME OF REMOVAL. MUCH THROMBUS WAS ALSO ATTACHED TO THE DISTAL END OF THE EMBOVAC. THE M2 OCCLUSION WAS THEN CONFIRMED. THE PHYSICIAN COMMENTED THAT THE M2 OCCLUSION WAS PROBABLY CAUSED BY CLOT EMBOLIZATION/MIGRATION TO NEW TERRITORY DURING THE FIRST OR SECOND PASS. THE PHYSICIAN TRIED TO INSERT THE MICROCATHETER INTO THE EMBOVAC CATHETER, BUT THIS ATTEMPT WAS UNSUCCESSFUL. IN THE END, THE PHYSICIAN REMOVED THE M2 THROMBUS WITH THE TRON STENT RETRIEVER. ON 28-DEC-2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE EMPLOYED A STENT-RETRIEVER INTO AN ASPIRATION CATHETER WITH PROXIMAL BALLOON (ASAP) TECHNIQUE. THE EMBOVAC DEVICE KINKED AFTER TWO PASSES. EXCESSIVE FORCE WAS NOT APPLIED. THE EVENT DID NOT RESULT IN ANY CONSEQUENCE NOR INJURY TO THE PATIENT. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30557977) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. EMBOLIZATION OF THROMBUS IS A KNOWN POTENTIAL COMPLICATION DURING MECHANICAL RESTORATION OF FLOW AND THROMBUS REMOVAL PROCEDURES IN WHICH THE EMBOVAC IS USED. DURING THESE INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH PRE-EXISTING THROMBOTIC LESIONS WITH RISK OF EMBOLIZATION OF THROMBUS. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL CHARACTERISTICS, PATIENT, AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ENT. DURING THE COURSE OF THE PROCEDURE, IT APPEARS THAT PART OF THE IC TOP CLOT DISLODGED TO A PREVIOUSLY UNAFFECTED TERRITORY. SINCE THE ALLEGED ENT NECESSITATED ADDITIONAL THROMBECTOMY PASS FOR RESTORATION OF BLOOD FLOW, AND THE RELATIONSHIP OF THE EMBOVAC TO THE REPORTED EVENT CANNOT BE EXCLUDED. CATHETER KINKING DURING CLINICAL USE IS A KNOWN AND COMMON OCCURRENCE OCCURRING DURING ANGIOGRAPHY AND IS TYPICALLY RELATED TO ANATOMY, TECHNIQUE, SKILL, AND VESSEL TORTUOSITY. THE INSTRUCTIONS FOR USE CAUTIONS USERS TO INSPECT FOR KINKS AND BENDS, OR OTHER SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. IF THE OPERATOR ENCOUNTERS KINKING OR DAMAGE DURING USE, THEY ARE CLINICALLY TRAINED TO IMMEDIATELY DISCONTINUE MANIPULATIONS AND REMOVE THE PRODUCT. THEREFORE, THE POTENTIAL FOR PATIENT INJURY/DEATH OCCURRING AS A RESULT OF KINKING OR BEND TYPE DAMAGE IS REMOTE. BASED ON THE MANUFACTURING DOCUMENTATION 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 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). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 11-JAN-2022. THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE, A 132CM EMBOVAC 71 ASPIRATION CATHETER (IC71132CA / 30557977) WAS USED TO REMOVE THROMBUS, BUT THE DISTAL END OF THE CATHETER BECAME KINKED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. ON 14-DEC-2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET OCCLUSION WAS LOCATED AT THE INTERNAL CAROTID (IC) TOP; THERE WAS ¿MUCH THROMBUS¿. THE FIRST PASS WAS MADE VIA ASPIRATION CATHETER WITH PROXIMAL BALLOON (ASAP) TECHNIQUE. THE EMBOVAC AND A 6MM TRON STENT RETRIEVER (BIOMEDICAL SOLUTIONS, INC.) WERE USED, AND SUCTION WAS PERFORMED WITH VACLOK® VACUUM PRESSURE SYRINGE (MERIT MEDICAL). THE TRON STENT RETRIEVER WAS REMOVED, AND THE EMBOVAC REMAINED AT THE TARGET OCCLUSION. ¿LITTLE¿ THROMBUS WAS REMOVED. ANGIOGRAPHY CONFIRMED THE PRESENCE OF THROMBUS AT THE IC TOP. THEREFORE, A SECOND PASS WAS MADE WITH THE SAME SYSTEM. HOWEVER, BACK-FLOW WAS STILL NOT CONFIRMED. THEREFORE, MANUAL SUCTION WAS PERFORMED, AND THE EMBOVAC AND THE TRON WERE REMOVED AS A UNIT. AFTER REMOVAL, IT WAS CONFIRMED THAT THE EMBOVAC HAD KINKED APPROXIMATELY 15 TO 30 CM FROM THE DISTAL END OF THE DEVICE. THERE WAS ¿MUCH¿ THROMBUS NOTED ON THE DISTAL END. IT WAS CONFIRMED THAT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) WAS OBSTRUCTED. THE PHYSICIAN TRIED TO USE THE COMPLAINT DEVICE, BUT THE TREVO TRAK 21 MICROCATHETER (STRYKER) FAILED TO ADVANCE. THROMBUS WAS REMOVED WITH THE 2MM TRON STENT RETRIEVER (ONLY) AND THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT THE M2 OBSTRUCTION WAS PROBABLY CAUSED BY CLOT MIGRATION/EMBOLIZATION TO NEW TERRITORY (ENT). ON 16-DEC-2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE EMBOVAC AND 6MM TRON WERE USED FOR THE FIRST PASS, BUT THE PHYSICIAN CONFIRMED THAT THE THROMBUS REMAINED AT THE IC-TOP. M2 OCCLUSION WAS NOT NOTED AT THIS TIME. THE SAME SYSTEM WAS USED AGAIN FOR THE SECOND PASS, BUT THE BACK FLOW FROM THE VACLOK SYRINGE WAS NOT CONFIRMED. THUS, MANUAL SUCTION WAS PERFORMED, AND THE DEVICES WERE REMOVED AS A UNIT. THE KINK IN THE EMBOVAC WAS NOTED AT THE TIME OF REMOVAL. MUCH THROMBUS WAS ALSO ATTACHED TO THE DISTAL END OF THE EMBOVAC. THE M2 OCCLUSION WAS THEN CONFIRMED. THE PHYSICIAN COMMENTED THAT THE M2 OCCLUSION WAS PROBABLY CAUSED BY CLOT EMBOLIZATION/MIGRATION TO NEW TERRITORY DURING THE FIRST OR SECOND PASS. THE PHYSICIAN TRIED TO INSERT THE MICROCATHETER INTO THE EMBOVAC CATHETER, BUT THIS ATTEMPT WAS UNSUCCESSFUL. IN THE END, THE PHYSICIAN REMOVED THE M2 THROMBUS WITH THE TRON STENT RETRIEVER. ON 28-DEC-2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE EMPLOYED A STENT-RETRIEVER INTO AN ASPIRATION CATHETER WITH PROXIMAL BALLOON (ASAP) TECHNIQUE. THE EMBOVAC DEVICE KINKED AFTER TWO PASSES. EXCESSIVE FORCE WAS NOT APPLIED. THE EVENT DID NOT RESULT IN ANY CONSEQUENCE NOR INJURY TO THE PATIENT. [ADDITIONAL INFORMATION]: ON 11-JAN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DETAILS RELATED TO THE CHARACTERISTICS OF THE BLOOD VESSELS ARE UNKNOWN OTHER THAN PER THE PHYSICIAN, THERE WAS NO EXTREME BENDING. THE ADDITIONAL INFORMATION ALSO INCLUDED PREVIOUSLY REPORTED INFORMATION. THE INFORMATION INDICATED THAT ON THE SECOND PASS, THERE WAS NO BACKFLOW. THE PHYSICIAN FELT AN ABNORMALITY AND THEN HE/SHE REMOVED THE COMPLAINT DEVICE AND CONFIRMED THE KINKING. THE 132CM EMBOVAC 71 ASPIRATION CATHETER WAS USED FOR THE FIRST AND SECOND PASSES. THE DEVICE WAS NOT IN USABLE STATE ON THE THIRD PASS. 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 A MECHANICAL THROMBECTOMY PROCEDURE, A 132CM EMBOVAC 71 ASPIRATION CATHETER (IC71132CA / 30557977) WAS USED TO REMOVE THROMBUS, BUT THE DISTAL END OF THE CATHETER BECAME KINKED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET OCCLUSION WAS LOCATED AT THE INTERNAL CAROTID (IC) TOP; THERE WAS ¿MUCH THROMBUS¿. THE FIRST PASS WAS MADE VIA ASPIRATION CATHETER WITH PROXIMAL BALLOON (ASAP) TECHNIQUE. THE EMBOVAC AND A 6MM TRON STENT RETRIEVER (BIOMEDICAL SOLUTIONS, INC.) WERE USED, AND SUCTION WAS PERFORMED WITH VACLOK® VACUUM PRESSURE SYRINGE (MERIT MEDICAL). THE TRON STENT RETRIEVER WAS REMOVED, AND THE EMBOVAC REMAINED AT THE TARGET OCCLUSION. ¿LITTLE¿ THROMBUS WAS REMOVED. ANGIOGRAPHY CONFIRMED THE PRESENCE OF THROMBUS AT THE IC TOP. THEREFORE, A SECOND PASS WAS MADE WITH THE SAME SYSTEM. HOWEVER, BACK-FLOW WAS STILL NOT CONFIRMED. THEREFORE, MANUAL SUCTION WAS PERFORMED, AND THE EMBOVAC AND THE TRON WERE REMOVED AS A UNIT. AFTER REMOVAL, IT WAS CONFIRMED THAT THE EMBOVAC HAD KINKED APPROXIMATELY 15 TO 30 CM FROM THE DISTAL END OF THE DEVICE. THERE WAS ¿MUCH¿ THROMBUS NOTED ON THE DISTAL END. IT WAS CONFIRMED THAT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) WAS OBSTRUCTED. THE PHYSICIAN TRIED TO USE THE COMPLAINT DEVICE, BUT THE TREVO TRAK 21 MICROCATHETER (STRYKER) FAILED TO ADVANCE. THROMBUS WAS REMOVED WITH THE 2MM TRON STENT RETRIEVER (ONLY) AND THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT THE M2 OBSTRUCTION WAS PROBABLY CAUSED BY CLOT MIGRATION/EMBOLIZATION TO NEW TERRITORY (ENT). ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE EMBOVAC AND 6MM TRON WERE USED FOR THE FIRST PASS, BUT THE PHYSICIAN CONFIRMED THAT THE THROMBUS REMAINED AT THE IC-TOP. M2 OCCLUSION WAS NOT NOTED AT THIS TIME. THE SAME SYSTEM WAS USED AGAIN FOR THE SECOND PASS, BUT THE BACK FLOW FROM THE VACLOK SYRINGE WAS NOT CONFIRMED. THUS, MANUAL SUCTION WAS PERFORMED, AND THE DEVICES WERE REMOVED AS A UNIT. THE KINK IN THE EMBOVAC WAS NOTED AT THE TIME OF REMOVAL. MUCH THROMBUS WAS ALSO ATTACHED TO THE DISTAL END OF THE EMBOVAC. THE M2 OCCLUSION WAS THEN CONFIRMED. THE PHYSICIAN COMMENTED THAT THE M2 OCCLUSION WAS PROBABLY CAUSED BY CLOT EMBOLIZATION/MIGRATION TO NEW TERRITORY DURING THE FIRST OR SECOND PASS. THE PHYSICIAN TRIED TO INSERT THE MICROCATHETER INTO THE EMBOVAC CATHETER, BUT THIS ATTEMPT WAS UNSUCCESSFUL. IN THE END, THE PHYSICIAN REMOVED THE M2 THROMBUS WITH THE TRON STENT RETRIEVER. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE EMPLOYED A STENT-RETRIEVER INTO AN ASPIRATION CATHETER WITH PROXIMAL BALLOON (ASAP) TECHNIQUE. THE EMBOVAC DEVICE KINKED AFTER TWO PASSES. EXCESSIVE FORCE WAS NOT APPLIED. THE EVENT DID NOT RESULT IN ANY CONSEQUENCE NOR INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2008923 | 132CM EMBOVAC 71 ASP. CATHETER | EMBOVAC ASPIRATION CATHETER | NRY | MEDOS INTERNATIONAL SARL | 30557977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | TREVO TRAK 21 MICROCATHETER (STRYKER)| TRON STENT RETRIEVER (BIOMEDICAL SOLUTIONS, INC.)| VACLOK® VACUUM PRESSURE SYRINGE (MERIT MEDICAL) |