FDA Adverse Event
Malfunction
Summary report: N
GUGLIELMI DETACHABLE COIL- GDC-10
MDR report key: 214944
·
Received March 16, 1999
Report
- Report Number
- 6000078-1999-00023
- Event Type
- Malfunction
- Date Received
- March 16, 1999
- Date of Event
- December 30, 1998
- Report Date
- March 15, 1999
- Manufacturer
- TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP.
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO TARGET THAT DURING A PROCEDURE, FRICTION WAS EXPERIENCED WHILE REPOSITONING THIS GDC-10 COIL. DURING RETRIEVAL, THE COIL BROKE. THE PROCEDURE WAS FINISHED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUGLIELMI DETACHABLE COIL- GDC-10 Implant | DETACHABLE COIL | HCG | TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP. | NA | A68580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | 1) BRAND NAME: ENVOY 6F, TYPE OF DEVICE: GUIDING| GUIDEWIRE.| A71564. 3) BRAND NAME: TRANSEND, TYPE OF DEVICE,| DEVICE: INFUSION CATHETER, CATALOG#: 104110, LOT#| CATHETER. 2) BRAND NAME: TRACKER-10, TYPE OF |