APOLLO
Report
- Report Number
- 2029214-2021-00243
- Event Type
- Malfunction
- Date Received
- March 4, 2021
- Date of Event
- February 16, 2021
- Report Date
- May 20, 2021
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- UDI-DI
- 00847536006010
- PMA / PMN Number
- P030004/S006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
H3: ANALYSIS OF THE APOLLO MICRO CATHETER (MODEL: 105-5095-000 LOT: B124049) FOUND THAT THE APOLLO MICRO CATHETER TOTAL LENGTH WAS MEASURED TO BE ~171.0 CM. THE APOLLO USABLE LENGTH WAS MEASURED TO BE ~164.9 CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 165.0 CM ± 2.5 CM). THE APOLLO DISTAL FLOPPY SEGMENT WAS MEASURED TO BE ~26.2 CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 25.0 CM +2 CM -1 CM). NO FLASH OR MOLDED VOIDS WERE OBSERVED WITH THE APOLLO MICRO CATHETER HUB. THE APOLLO MICRO CATHETER BODY WAS FOUND TO BE WAVY AT ~40.2 CM FOR ~14.0 CM FROM DISTAL TIP. THE APOLLO MICRO CATHETER WAS FLUSHED, WATER AND WHAT APPEARED TO BE BLOOD EXITED FROM THE DISTAL TIP. THE APOLLO MICRO CATHETER BODY WAS THEN TESTED WITH AN IN-HOUSE MIRAGE GUIDEWIRE (MODEL: 103-0608 LOT: 9580171). THE MIRAGE GUIDEWIRE WAS ABLE TO PASS THROUGH THE APOLLO MICRO CATHETER HUB AND SUBSEQUENTLY THROUGH THE INNER LUMEN AND TIP WITHOUT ISSUE. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RESISTANCE¿ COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. NO DAMAGES WERE FOUND WITH THE RETURNED APOLLO MICRO CATHETER THAT WOULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE. IN ADDITION, AN IN-HOUSE MIRAGE GUIDEWIRE WAS ABLE TO PASS THROUGH THE RETURNED APOLLO MICRO CATHETER WITHOUT ISSUE. POSSIBLE CONTRIBUTING FACTORS TO ¿CATHETER RESISTANCE¿ INCLUDE THE USE OF AN INCOMPATIBLE DEVICE, FAILURE TO PREPARE THE ANCILLARY DEVICES PRIOR TO USE, AND INSUFFICIENT CATHETER FLUSH. PER AN ONLINE SOURCE THE BALT HYBRID GUIDEWIRE HAS A LABELED OD (OUTER DIAMETER) OF 0.008¿. PER THE APOLLO MICRO CATHETER IFU (INSTRUCTIONS FOR USE), THE APOLLO MICRO CATHETER IS COMPATIBLE FOR USE WITH AN .008¿ AND .010¿ GUIDEWIRE. THEREFORE, THE BALT HYBRID GUIDEWIRE WAS FOUND TO BE COMPATIBLE FOR USE WITH THE APOLLO MICRO CATHETER. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER ACCORDION¿ WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER REPORTED VESSEL TORTUOSITY TO BE SEVERE. THE REPORTED VESSEL TORTUOSITY MAY HAVE CONTRIBUTED TO THE CATHETER DAMAGE (ACCORDION). H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO C070601. CONCLUSION CODE UPDATED TO D15. 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. 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.
NO ADDITIONAL INFORMATION RECEIVED.
ADDITIONAL INFORMATION CLARIFIED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER NECESSITATING THE REMOVAL OF BOTH AS A SYSTEM/UNIT.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION REGARDING AN APOLLO CATHETER WHICH HAD RESISTANCE AND THE GUIDEWIRE BECAME STUCK AT THE TIP. THE PATIENT WAS UNDERGOING A PROCEDURE FOR EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA) VIA RIGHT RADIAL ACCESS. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AND THE CATHETER FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, THE NON-MEDTRONIC GUIDEWIRE BECAME STUCK AT THE TIP OF THE APOLLO CATHETER AND CAUSED ACCORDION DAMAGE TO THE CATHETER. IT WAS NOTED THAT THE CATHETER WAS ENTRAPPED AND REMOVAL WAS DIFFICULT. THE SYSTEM WAS REMOVED TOGETHER AND REPLACED. ACCESS TO THE MMA WAS THEN REGAINED TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT DID NOT EXPERIENCE VASOSPASM. THERE WERE NO A DDITIONAL SURGICAL OR MEDICAL INTERVENTION NECESSARY. ANCILLARY DEVICE: BALT HYBRID .008J GUIDEWIRE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309128 | APOLLO | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | 105-5095-000 | B124049 | 00847536006010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |