SCEPTER MINI
Report
- Report Number
- 2032493-2021-00007
- Event Type
- Injury
- Date Received
- January 9, 2021
- Date of Event
- December 8, 2020
- Report Date
- January 6, 2021
- Manufacturer
- MICROVENTION, INC.
- Product Code
- MJN
- UDI-DI
- 00842429106563
- PMA / PMN Number
- K110741
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
THE RETURNED DEVICE WAS SEVERELY DAMAGED. THE BALLOON IS RUPTURED AND DETACHED, AND THE LUMEN IS TORN; THEREFORE IT IS NOT POSSIBLE TO PERFORM FUNCTIONAL TESTING FOR BALLOON INFLATION. THE ALLEGED COMPLAINT CANNOT BE CONFIRMED.
A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.
IT WAS REPORTED THAT DURING EMBOLIZATION OF AN AVM WITH A LIQUID EMBOLIC, THE SCEPTER MINI WOULD NOT DEFLATE AND THEN COULD NOT BE REMOVED FROM THE SUPERIOR CEREBELLAR ARTERY (SCA). DURING AN ATTEMPT TO REMOVE THE SCEPTER WITH A SNARE DEVICE, THE BALLOON DETACHED FROM THE CATHETER IN THE SCA. THE PROXIMAL SEGMENT OF THE SCA BECAME OCCLUDED AND CEREBRAL INFARCTION DEVELOPED, LEADING TO BRAINSTEM COMPRESSION AND HYDROCEPHALUS. VENTRICULAR DRAINAGE, AVM REMOVAL, AND EXTERNAL DECOMPRESSION WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40544 | SCEPTER MINI | VASCULAR CLAMP | MJN | MICROVENTION, INC. | BC0210M-US | 2001091MX | 00842429106563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Hospitalization| L| R| S |