FDA Adverse Event
Malfunction
Summary report: N
MICROPLEX HYPERSOFT HELICAL HYPERSOFT
MDR report key: 4852994
·
Received June 16, 2015
Report
- Report Number
- 2032493-2015-00087
- Event Type
- Malfunction
- Date Received
- June 16, 2015
- Date of Event
- April 28, 2015
- Report Date
- May 22, 2015
- Manufacturer
- MICROVENTION, INC.
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DELIVERY PUSHER AND COIL WERE RETURNED FOR EVAL AND CONFIRMED THE IMPLANT COIL WAS STRETCHED AND DETACHED. THE EVALUATION SHOWS EXCESSIVE FORCE WAS USED WHICH LIKELY LET TO THE COIL BECOMING DETACHED. (B)(4).
Description of Event or Problem · 1
COILING TREATMENT WAS CONDUCTED OF AN ANEURYSM. UPON POSITIONING THE COIL, IT WAS REPORTED TO PREMATURELY DETACH WITHIN THE MICROCATHETER. THE CATHETER AND COIL WERE REMOVED TOGETHER SUCCESSFULLY. NO INJURY WAS REPORTED WITH THE PT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392604 | MICROPLEX HYPERSOFT HELICAL HYPERSOFT | EMBOLIZATION COIL | HCG | MICROVENTION, INC. | 100308HS-V-A-CN | 141031E2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |