FDA Adverse Event
Injury
Summary report: N
GDC 10-ULTRASOFT STRETCH RESISTANT COIL SYNERG DETECTION CIR
MDR report key: 439037
·
Received January 20, 2003
Report
- Report Number
- 6000078-2002-00219
- Event Type
- Injury
- Date Received
- January 20, 2003
- Date of Event
- December 19, 2002
- Report Date
- January 17, 2003
- Manufacturer
- TARGET THERAPEUTICS/A DIV OF BOSTON SCIENTIFIC CORP
- Product Code
- HCG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE GDI 10-ULTRASOFT STRETCH RESISTANT COIL SYNERG DETECTION CIRCUIT GOT ENTANGLED IN THE FIRST NEUROFORM STENT. COULD NOT REMOVE THE COIL. CORRECTIVE ACTION TAKEN; HAD TO STRETCH AND BREAK THE COIL. THEN TRIED TO JAIL COIL FRAGMENT TO THE ARTERY WALL WITH ANOTHER NEUROFORM STENT. THE NEUROFORM STENT WOULD NOT DEPLOY DUE TO HEAVY FRICTION WITH THE 2F STABILIZER. REMOVED UNDEPLOYED NEUROFORM STENT AND COIL FRAGMENT WITH A MICROVENOUS SNARE. IN THE PROCESS OF MANIPULATING THE SYSTEM, RUPTURED DISTAL M2 BRANCH WITH THE TRANSEND 300 FLOPPY. REMOVED EVERYTHING FROM THE PATIENT. PATIENT WAS RUSHED TO CT SCAN THEN WENT TO THE OPERATING ROOM THE FOLLOWING DAY TO HAVE CRANIOTOMY TO REMOVE THE CLOT IN THE BRAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC 10-ULTRASOFT STRETCH RESISTANT COIL SYNERG DETECTION CIR | DETACHABLE COIL | HCG | TARGET THERAPEUTICS/A DIV OF BOSTON SCIENTIFIC CORP | * | 4794887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Life Threatening| R | NEUROFORM MICRODEL STENT, CATALOG#: S04502, LOT#:| TRANSEND .104" FLOPPY 300 CM, CATALOG# 468150, LOT| NOV02034U, EXPIRATION DATE: 09/01/2003, BRAND NAME| BRAND NAME: MICROVENEA SNARE: BRAND NAME:| 5119375, EXPIRATION DATE#: 10/01/2004. |