FDA Adverse Event
Malfunction
Summary report: N
TARGET COIL
MDR report key: 2213175
·
Received August 16, 2011
Report
- Report Number
- 2939204-2011-00409
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 30, 2011
- Report Date
- August 5, 2011
- Manufacturer
- BOSTON SCIENTIFIC - CORK
- Product Code
- HCG
- PMA / PMN Number
- K093142
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THE DELIVERY WIRE BROKE AS THE DEVICE WAS ADVANCED AGAINST SIGNIFICANT RESISTANCE THROUGH THE INTRODUCER SHEATH. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT IS MOST LIKELY THAT THE REPORTED EVENT WAS DUE TO OPERATIONAL CONTEXT.
Description of Event or Problem · 1
THE PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE ADVANCING THE DEVICE THROUGH THE INTRODUCER SHEATH TO ADVANCE THE COIL INTO THE MICROCATHETER. THIS RESISTANCE RESULTED IN THE DELIVERY WIRE BENDING AND THEN BREAKING. THERE WAS NO CONTACT WITH THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET COIL | DEVICE, NEUROVASCULAR EMBOLIZATION | HCG | BOSTON SCIENTIFIC - CORK | M0035432060 | 14177771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |