FDA Adverse Event
Injury
Summary report: N
MICRUS MICROCOIL SYSTEM
MDR report key: 2092560
·
Received May 3, 2011
Report
- Report Number
- 2954740-2011-00021
- Event Type
- Injury
- Date Received
- May 3, 2011
- Date of Event
- April 3, 2011
- Report Date
- April 6, 2011
- Manufacturer
- MICRUS ENDOVASCULAR CORPORATION
- Product Code
- MJN
- PMA / PMN Number
- K091504
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RECEIVED IN THE FACILITY AT THIS TIME. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE PRODUCT IS RECEIVED AND A FINAL EVAL ANALYSIS HAS BEEN CONDUCTED.
Description of Event or Problem · 1
PER RECEIVED REPORT: THE PHYSICIAN WAS COILING AN INTERNAL CAROTID ARTERY (ICA) TERMINATION ANEURYSM THROUGH A BALLOON. AS HE SWITCHED TO AN SL-10 MICROCATHETER TOWARDS THE END, RESISTANCE WAS FELT AND DECIDED TO WITHDRAW THE COIL. WHILE WITHDRAWING WITHOUT MUCH RESISTANCE, A "POP" WAS FELT AND THE COIL HAD BROKEN. AN ATTEMPT WAS MADE TO PULL THE COIL, BUT IT STRETCHED FURTHER. A SNARE WAS USED TO PULL THE COIL BACK TO NO AVAIL. NO COMPLICATION WAS REPORTED SINCE THERE WAS NO PULL OR PUSH FACTOR. THE INCIDENT OCCURRED RIGHT IN THE BEGINNING OF THE COIL DEPLOYMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRUS MICROCOIL SYSTEM | EMBOLIC COIL | MJN | MICRUS ENDOVASCULAR CORPORATION | G12272 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |