FDA Adverse Event
Injury
Summary report: N
CORDIS WEBSTER 7 FR, "C" CURVE, THERMISTOR
MDR report key: 188393
·
Received September 17, 1998
Report
- Report Number
- 2020638-1998-00002
- Event Type
- Injury
- Date Received
- September 17, 1998
- Date of Event
- August 13, 1998
- Report Date
- August 25, 1998
- Manufacturer
- CORDIS WEBSTER, INC.
- Product Code
- DQO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FOLLOWING INFO WAS REPORTED BY A CORDIS WEBSTER REP AND WAS NOT CONFIRMED BY THE PHYSICIAN, AS HE DID NOT RELEASE INFO ON THIS EVENT DUE TO PT CONFIDENTIALITY. IT WAS REPORTED THAT THE PT WAS DIFFICULT AND DID NOT HAVE GOOD EXPERIENCE THROUGHOUT THE PROCEDURE. DURING ABLATION, THE PHYSICIAN NOTICED THAT THE BLOOD PRESSURE WENT FROM 130 TO 100 TO 63 IN 7-10 MINUTE TIME FRAMES. ULTRASOUND WAS PERFORMED AND TAMPONADE WAS DISCOVERED. THE PT UNDERWENT PERICARDIOCENTESIS AND THE RESULTING EFFUSION WITHOUT FURTHER SURGICAL TREATMENT. THE PT WAS ADMITTED TO THE HOSP FOR FOUR DAYS AND RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDIS WEBSTER 7 FR, "C" CURVE, THERMISTOR | * | DQO | CORDIS WEBSTER, INC. | D-1200-03-S | 803079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | HEPARIN WAS USED |