FDA Adverse Event
Other
Summary report: N
CORONARY IMAGING CATHETER
MDR report key: 538272
·
Received August 9, 2004
Report
- Report Number
- 6000084-2004-00005
- Event Type
- Other
- Date Received
- August 9, 2004
- Date of Event
- June 8, 2004
- Report Date
- August 6, 2004
- Manufacturer
- SCIMED, A DIVISION OF FSC
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AS REPORTED BY BSC REP: AFTER DELIVERING GUIDEWIRE (GW) TO RCA, CATHETER GOT STUCK WITH GW. PHYSICIAN INITIALLY TRIED TO WITHDRAW CATHETER ALONG WITH THE GW, AND WAS NOT ABLE. BOTH PARTS WERE REMOVED DURING SUBSEQUENT ATTEMPT, HOWEVER IT WAS NOTICED A PORTION OF CATHETER TIP HAD BEEN DETACHED AND STAYED INSIDE. PHYSICIAN FELT THAT INCIDENT MAY HAVE OCCURRED BECAUSE THE STENT DEPLOYMENT WAS NOT FULL, ALLOWING FOR A SPACE BETWEEN ITS OUTER SURFACE AND VESSEL WALL, WHICH LED TO CATHETER TIP TO GET TRAPPED AND STUCK TO THE STENT. THE DETACHED PORTION OF THE TIP REMAINS IN PT. PT CONDITION IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORONARY IMAGING CATHETER | INTRAVASCULAR ULTRASOUND IMAGING CATH SYSTEM | DQO | SCIMED, A DIVISION OF FSC | 38942 | 6357523 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |