NC EUPHORA RX
Report
- Report Number
- 9612164-2023-05461
- Event Type
- Injury
- Date Received
- November 21, 2023
- Date of Event
- November 10, 2023
- Report Date
- January 30, 2024
- Manufacturer
- MEDTRONIC MEXICO
- Product Code
- LOX
- PMA / PMN Number
- K141090
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX BALLOON CATHETER TO TREAT EXTENSIVE CALCIFICATION, A NON-TORTUOUS LESION WITH 70-80% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION HAD AN OLD STENT WITH RESTENOSIS. A CONCENTRATION OF 50/50 CONTRAST/SALINE WAS USED. THE DEVICE WAS BEING USED TO POST DILATE A DEPLOYED STENT. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. A NON-MEDTRONIC GEC WAS USED AND THE BALLOON WAS REMOVED SUCCESSFULLY. EXTENSIVE FORCE WAS USED DURING REMOVAL AS THE BALLOON DID NOT GO INTO THE GEC BUT IT HELD THE BALLOON AT THE DISTAL PART. THE NON-MEDTRONIC WIRE, THE NC EUPHORA DEVICE AND THE NON-MEDTRONIC GEC WERE REMOVED ALL TOGETHER, HOWEVER THIS CAUSED A DISSECTION. THE DISSECTION OCCURRED WHEN PULLING OUT THE NON-DEFLATED BALLOON. IT IS BELIEVED THE NC EUPHORA BALLOON CAUSED AND CONTRIBUTED TO THE REPORTED DISSECTION. IT WAS STATED THAT THREE LONG ONYX TRUSTAR STENTS WERE USED TO SUCCESSFULLY COVER THE DISSECTION WITH NO ISSUES NOTED. A LAUNCHER CATHETER WAS ALSO USED IN THE PROCEDURE WITH NO ISSUES NOTED. THE LAUNCHER WAS INSPECTED WITH NO ISSUES NOTED. THE SCRATCHES FOUND DURING DEVICE ANALYSIS WAS MOST LIKELY DUE TO THE ATTEMPT TO DEFLATE THE BALLOON WITH A STIFF WIRE AND REMOVAL ATTEMPTS. THE TELESCOPE OR THE LAUNCHER DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION. IT WAS CLARIFIED THAT AN ATTEMPT WAS MADE TO USE THE TELESCOPE, HOWEVER THE TELESCOPE WAS SWITCHED OVER TO THE NON-MEDTRONIC GEC. THE NON-MEDTRONIC GEC WAS BEING USED WHEN THE DISSECTION OCCURRED. ANNEX D CODES ADDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION: VIDEO IMAGES CONFIRM THE PRESENCE OF AN INFLATED BALLOON IN THE DISTAL RCA WITH A GUIDE EXTENSION CATHETER PRESENT IN THE MID VESSEL. THE BALLOON REMAINS INFLATED AND A GUIDE EXTENSION CATHETER HAS BEEN DELIVERED INTO THE MID VESSEL TO SUPPORT ATTEMPTS TO DEFLATE AND REMOVE THE BALLOON. CONTRAST INJECTION INTO RCA SHOWING THAT THE BALLOON CONTINUES TO BLOCK FLOW TO THE DISTAL VESSEL. THE WIRE AND ADDITIONAL GEC CAN BE SEEN IN THE IMAGES BUT THE ACTUAL DEFLATION/REMOVAL OF THE BALLOON IS NOT CAPTURED OR PROVIDE ON THIS IMAGE. SUBSEQUENT IMAGES SHOW THE DELIVERY OF A DISTAL STENT THAT WAS DEPLOYED IN THE INITIAL LESION. THE STENT PROFILE WAS INITIAL IRREGULAR SUPPORTING THE FACT THAT THE LESION WAS SEVERELY DISEASED. ANOTHER LONG MORE PROXIMAL STENT WAS THEN DELIVERED AND DEPLOYED SUCCESSFUL. THE FLOW TO THE RCA WAS RESTORED. THE IMAGES FAILED THE IDENTIFY A ROOT CAUSE OF THE DEFLATION DIFFICULTIES AFTER THE 3RD INFLATION OF THE NC EUPHORA BALLOON. A LAUNCHER CATHETER WAS ALSO USED IN THE PROCEDURE WITH NO ISSUES NOTED. PRODUCT ANALYSIS: THE DEVICE WAS RECEIVED FOR ANALYSIS. THE DEVICE RETURNED LOADED IN A 6FR LAUNCHER GUIDE CATHETER. THE LUER WAS REMOVED FROM THE DEVICE AS REPORTED AND A SECTION OF THE BALLOON WAS OBSERVED EXITING THE TIP OF THE GUIDE CATHETER. A NON-MDT GEC AND GUIDE WIRE WERE ALSO LOADED THROUGH THE GUIDE CATHETER AND A NON-MDT Y-CONNECTOR WAS ATTACHED TO THE HUB OF THE GUIDE CATHETER. UPON INSPECTION OF THE BALLOON SECTION, IT WAS NOTED IT WAS PARTIALLY INFLATED WITH CONTRAST PRESENT INSIDE THE BALLOON. THE BALLOON MATERIAL HAD PARTIALLY PULLED OVER THE TIP AND WAS FOLDED IN ON ITSELF. IT WAS NOT POSSIBLE TO REMOVE THE NC EUPHORA BALLOON DUE TO ITS CONDITION. THE DEVICE WAS CONFIRMED AS ENTRAPPED, HOWEVER BECAUSE THE LUER WAS REMOVED IT WAS POSSIBLE TO REMOVE THE DEVICE DISTALLY FROM THE GUIDE CATHETER FOR FURTHER ANALYSIS. FURTHER INSPECTION CONFIRMED THE HYPOTUBE WAS CUT TO REMOVE THE LUER AND NUMEROUS KINKS WERE EVIDENT ON THE HYPOTUBE. THE LENGTH OF THE DISTAL SHAFT AND THE PROXIMAL BALLOON BOND WAS STRETCHED. A KINK WAS ALSO NOTED ON THE DISTAL SHAFT. BLOOD WAS VISIBLE ALONG THE LENGTH OF THE GUIDEWIRE LUMEN. THE ENTIRE BALLOON WAS INSPECTED WITH NO FURTHER OBSERVATIONS TO NOTE. DEFORMATION WAS EVIDENT TO THE DISTAL TIP. IT WAS NOT POSSIBLE TO PERFORM A NEGATIVE PREP TEST OR DEFLATION TEST DUE TO THE CONDITION OF THE DEVICE. THERE WAS NO OTHER DAMAGE EVIDENT TO THE REMINDER OF THE DEVICE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION: IT WAS NOT DIFFICULT TO REMOVE THE PROTECTIVE SHEATH OR THE PACKAGING STYLETTE. THE HUB WAS CUT INTENTIONALLY, WHICH ALLOWED THE NON-MEDTRONIC GEC TO APPROACH ALL THE WAY TO THE BALLOON. THE NON MEDTRONIC WIRE, THE NC EUPHORA DEVICE AND THE NON MEDTRONIC GEC WERE REMOVED ALL TOGETHER, HOWEVER THIS CAUSED A DISSECTION. THE TELESCOPE OR THE STIFF WIRE DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION. THE BALLOON WAS MOVED OR REPOSITIONED WHILE INFLATED. PATIENT SEX , WEIGHT PROVIDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX BALLOON CATHETER TO TREAT A LESION WITH 70-80% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES AND REMOVAL DIFFICULTIES OCCURRED. IT WAS DETAILED THAT THE BALLOON WAS USED TWICE WITH NORMAL FUNCTION AND AFTER THE THIRD INFLATION AT 16ATM THE BALLOON FAILED TO DEFLATED. THE BALLOON WAS INSIDE THE STENT MOVED APPROXIMATELY 20MM AND BECAME STUCK IN THE STENOSIS. SEVERAL ATTEMPTS WERE MADE TO DEFLATE BALLOON WITH NO SUCCESS. A TELESCOPE GUIDE EXTENSION CATHETER (GEC) WAS USED TO RETRIEVE THE INFLATED BALLOON BUT WAS UNSUCCESSFUL. AN ATTEMPT WAS MADE TO PUNCTURE BALLOON WITH A STIFF WIRE BUT WITH NO SUCCESS. A NON-MEDTRONIC GEC WAS THEN USED WHICH FINALLY SUCCEEDED IN REMOVING THE BALLOON. HOWEVER, IT CAUSED A DISSECTION. IT WAS STATED THAT THREE LONG STENTS WERE USED TO SUCCESSFULLY COVER THE DISSECTION. NO FURTHER PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2068874 | NC EUPHORA RX | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, | LOX | MEDTRONIC MEXICO | NCEUP3015X | 227146097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Required Intervention |