HYPERFORM LINE EXTENSION
Report
- Report Number
- 2029214-2023-02129
- Event Type
- Malfunction
- Date Received
- October 30, 2023
- Date of Event
- October 26, 2023
- Report Date
- January 23, 2024
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MJN
- UDI-DI
- 00763000294298
- PMA / PMN Number
- K101570
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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.
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.
PRODUCT ANALYSIS #705927882: AS FOUND CONDITION: THE HYPERFORM OCCLUSION BALLOON CATHETER AND GUIDEWIRE WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND A PLASTIC BIO-POUCH. DAMAGE LOCATION DETAILS: NO DAMAGES WERE FOUND WITH THE HYPERFORM CATHETER HUB. THE HYPERFORM CATHETER BODY WAS FOUND DAMAGED (KINKED) AT ~85.0CM FROM THE PROXIMAL END OF THE CATHETER HUB. UPON VISUAL INSPECTION, THE HYPERFORM BALLOON CATHETER TIP APPEARS TO BE IN GOOD CONDITION. NO BENDS OR KINKS WERE FOUND WITH THE GUIDEWIRE. TESTING/ANALYSIS: THE HYPERFORM OCCLUSION BALLOON CATHETER WAS FLUSHED, AND WATER EXITED FROM THE DISTAL TIP. THE GUIDEWIRE WAS HY DRATED AND INSERTED THROUGH THE HYPERFORM OCCLUSION BALLOON CATHETER WITHOUT ISSUE. THE BALLOON WAS INFLATED; HOWEVER, A LEAK WAS DETECTED AT THE DISTAL TIP, DISTAL TO THE DISTAL MARKER. UPON MICROSCOPIC INSPECTION, A HOLE WAS FOUND IN THE BALLOON CHRONOPRENE TUBI NG AT THE LOCATION OF THE LEAK. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S "NO/SLOW INFLATION DURING SET UP" AND "CATHETER LEAK" REPORTS WERE CONFIRMED. THE DAMAGE FOUND WITH THE HYPERFORM BALLOON (HOLE) LIKELY CONTRIBUTED TO THE EVENT. HOWEVER, THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. 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.
ON (B)(6) 2023 MPXR 1111735 (REP, HCP, FOR, DIS): MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE AND PERFORMING HYDRATION, IT WAS DISCOVERED THAT THE BALLOON WAS LEAKING AND COULD NOT BE INFLATED. REPLACED THE PRODUCT TO COMPLETE THE SURGERY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE LESION CHARACTERISTICS WERE ANEURYSM, OPHTHALMIC SEGMENT OF INTERNAL CAROTID ARTERY, 5 MM, SUPERIOR. VESSEL TORTUOSITY WAS NORMAL. TRIED MULTIPLE TIMES ACCORDING TO THE OPERATING PROCEDURES TO RESOLVE THE CATHETER LEAK. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER DEVICE. THERE WAS NOT EXTENSIVE GUIDEWIRE MANIPULATION. THE MATCHING GUIDEWIRE WAS USED. DURING INFLATION THE GUIDEWIRE TIP WAS 7MM FROM THE CATHETER TIP. THE PHYSICIAN DID NOT SHAPE THE GUIDEWIRE TIP. THE CONTRAST RATIO WAS 1:1. THE INJECTION RATE WAS SLOW. AIR LEAKAGE WAS USED TO DEFLATE THE BALLOON. NO CONTRAST WAS OBSERVED LEAKING DURING INFLATION. THERE WERE NO KINKS IN THE CATHETER DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156234 | HYPERFORM LINE EXTENSION | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY | MJN | MICRO THERAPEUTICS, INC. DBA EV3 | 104-4715 | B525261 | 00763000294298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female |