FDA Adverse Event
Injury
Summary report: N
GDC 10-ULTRASOFT STRETCH RESISTANT COIL
MDR report key: 1040575
·
Received May 8, 2008
Report
- Report Number
- 2939204-2008-00167
- Event Type
- Injury
- Date Received
- May 8, 2008
- Report Date
- April 8, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- HCG
- PMA / PMN Number
- K002181
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE CODE: OTHER (LONG DETACHMENT TIME OF THE COIL OCCURRED, BUT NO RELATIONSHIP WAS CONFIRMED BETWEEN THE DETACHMENT TIME OF THE COIL AND THE ADVERSE EVENT BY THE USER FACILITY).
Description of Event or Problem · 1
PATIENT WITH AN ANEURYSM IN THE A2 SEGMENT UNDERWENT A COILING EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT TOOK APPROX THREE MINUTES TO DETACH THE COIL. DURING FLUOROSCOPY, THROMBOSE AT THE ADJACENT A2 AND A3 SEGMENTS WERE OBSERVED. POST MEDICATIONS OF ASPIRIN, LIQUEMINE, AND NO LYSIS WERE ADMINISTERED. PT IS SLOWLY RECOVERING FROM LIMB MONOPLEGIA. NO RELATIONSHIP WAS CONFIRMED BETWEEN THE DETACHMENT TIME OF THE COIL AND THE ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC 10-ULTRASOFT STRETCH RESISTANT COIL | HCG: NEUROVASCULAR EMBOLIZAITON COIL | HCG | BOSTON SCIENTIFIC CORP. | 343203 | 8627187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |