FDA Adverse Event
Malfunction
Summary report: N
GUGLIELMI DETACHABLE COIL (GDC-10)
MDR report key: 177035
·
Received July 8, 1998
Report
- Report Number
- 6000078-1998-00084
- Event Type
- Malfunction
- Date Received
- July 8, 1998
- Date of Event
- April 1, 1998
- Report Date
- July 8, 1998
- Manufacturer
- TARGET THERAPEUTICS A BOSTON SCIENTIFIC CO
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TARGET WAS INFORMED THAT DURING THE PROCEDURE THE "GDC" COIL BROKE WHILE INSIDE THE MICROCATHER. TARGET DID NOT RECEIVE INFO ON THIS COMPLAINT UNTIL 6/10/98. THE PT'S HEALTH WAS NOT AFFECTED BY THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUGLIELMI DETACHABLE COIL (GDC-10) Implant | DETACHABLE COIL | HCG | TARGET THERAPEUTICS A BOSTON SCIENTIFIC CO | NA | A51481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | IMPLANT DATE: NA, EXPLANT DATE: NA.| DATE: NI, IMPLANT DATE: NA, EXPLANT DATE: NA.| NA ENVOY 6F, TYPE OF DEVICE: GUIDING CATHETER,| MODEL#: NA, CATALOG#: NA, LOT#: NA, EXP. DATE: NI,| 1) FASTRACKER-18 MX, INFUSION CATHETER| MODEL#: NA, CATALOG#: 134XXX, LOT#: NA, EXP. |