LRS INSTANT DETACHER
Report
- Report Number
- 2029214-2021-01287
- Event Type
- Malfunction
- Date Received
- October 15, 2021
- Date of Event
- October 12, 2021
- Report Date
- January 4, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- HCG
- PMA / PMN Number
- K060747
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
H3: THE INSTANT DETACHER WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND WITHIN THREE PLASTIC BIOHAZARD POUCHES. THE UNKNOWN AXIUM COIL USED IN THE EVENT WAS NOT RETURNED FOR ANALYSIS. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGES OR IRREGULARITIES WERE VISUALLY FOUND WITH THE OUTER SHELL OF THE INSTANT DETACHER. NO PUSHER WAS FOUND WITHIN THE INSTANT DETACHER CAP HOLE. THE INSTANT DETACHER WAS TAKEN APART TO EVALUATE THE COMPONENTS. THE SURFACE AROUND THE BOTTOM INNER DIAMETER OF THE INSTANT DETACHER CAP APPEARED TO BE DIRTY, AND DAMAGED (CHIPPED/COMPRESSED), WITH PART OF THE HOLE OBSTRUCTED BY A PORTION OF THE COMPRESSED CAP. TESTING/ANALYSIS: THE INNER DIAMETER OF THE CAP HOLE COULD NOT BE ACCURATELY MEASURED DUE TO THE DAMAGES. HOWEVER, THE SMALLEST INNER DIAMETER WAS MEASURED TO BE 0.0130¿ WHICH IS NO LONGER WITHIN SPECIFICATION (SPECIFICATION: 0.0145¿ ± 0.0010¿). AN IN-HOUSE AXIUM COIL WAS THEN USED FOR DETACHMENT TESTING. THE PUSHER FAILED TO BE INSERTED INTO THE INSTANT DETACHER AS IT BECAME STUCK AT THE COUPLER TUBE. CONCLUSION: BASED ON THE DEVICE ANALYSIS, THE CUSTOMER REPORT OF ¿PUSHER STUCK IN INSTANT DETACHER¿ WAS CONFIRMED. IN-HOUSE TESTING FOUND RESISTANCE AT THE CAP DUE TO THE DAMAGES FOUND ON THE CAP. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE CAP BECAME DAMAGED DURING THE ATTEMPT TO REMOVE THE STUCK PUSHER AFTER DETACHMENT. NO OTHER IRREGULARITIES WERE FOUND WITH INSTANT DETACHER THAT WOULD CONTRIBUTE TOWARDS THE PUSHER STUCK IN INSTANT DETACHER. AS THE UNKNOWN AXIUM COIL USED IN THE EVENT WAS NOT RETURNED FOR ANALYSIS, ANY CONTRIBUTION OF THE AXIUM COIL TOWARDS THE FAILURE COULD NOT BE DETERMINED. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A POTENTIAL MANUFACTURING ISSUE. 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE COIL DETACHMENT, THE AXIUM DELIVERY PUSHER (PROXIMAL SIDE INSERTED INTO THE DETACHER) DID NOT DETACH FROM THE DETACHER. SUBSEQUENTLY, THE IT WAS SEPARATED. IT WAS INDICATED THE DEVICE WAS PREPARED AS ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1539787 | LRS INSTANT DETACHER | DEVICE, NEUROVASCULAR EMBOLIZATION | HCG | MICRO THERAPEUTICS, INC. DBA EV3 | ID-1-5 | B198707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |