FDA Adverse Event
Malfunction
Summary report: N
HELIPAQ 10 MICRO COIL
MDR report key: 4091870
·
Received August 19, 2014
Report
- Report Number
- 4091870
- Event Type
- Malfunction
- Date Received
- August 19, 2014
- Date of Event
- August 18, 2014
- Report Date
- August 19, 2014
- Manufacturer
- MICRUS ENDOVASCULAR
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
Narratives
Description of Event or Problem · 1
PATIENT PRESENTED FOR TREATMENT OF EXTERNAL CAROTID ARTERY (ECA), EXTERNAL JUGULAR VEIN (EJV), AND RETROMANDIBULAR ARTERIOVENOUS FISTULA. DOING ENDOVASCULAR COILING OF THE FISTULOUS VENOUS POUCH, THE DELIVERY WIRE FRACTURED AND MULTIPLE ATTEMPTS TO RETRIEVE WERE UNSUCCESSFUL. THE DISTAL END OF THE WIRE WAS SEEN IN THE RIGHT COMMON FEMORAL ARTERY (CFA). THE PATIENT TAKES ASPIRIN AS HER SINGLE HOME MEDICATION AND WAS INSTRUCTED TO CONTINUE TAKING THIS. THE PROCEDURE WAS COMPLETED AND THE FISTULA SUCCESSFULLY DISCONNECTED. THE PATIENT IS CURRENTLY IN RECOVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500222 | HELIPAQ 10 MICRO COIL | DEVICE, EMBOLIC COIL | HCG | MICRUS ENDOVASCULAR | * | F76861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |