FDA Adverse Event
Malfunction
Summary report: N
RADIFOCUS INTRODUCER KIT
MDR report key: 1323583
·
Received February 4, 2009
Report
- Report Number
- 1118880-2009-00004
- Event Type
- Malfunction
- Date Received
- February 4, 2009
- Manufacturer
- TERUMO MEDICAL CORP.
- Product Code
- DYB
- PMA / PMN Number
- K954234
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PER THE ATTACHED USER FACILITY MEDWATCH REPORT, THE EVENT IS DESCRIBED AS FOLLOWS: "VENOUS SHEATH CATHETER FRACTURED APPROX 1/2 INCH FROM HUB DURING SHEATH PULL. SHEATH REMOVAL POST CARDIAC CATHETERIZATION". FOLLOW-UP COMMUNICATION WITH THE INITIAL REPORTER AT THE USER FACILITY CONFIRMED THAT THE PT WAS TAKEN TO THE OR AND THE DETACHED MATERIAL WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. THE PT WAS DISCHARGED TO HOME AND THEIR CONDITION WAS REPORTED TO BE "STABLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIFOCUS INTRODUCER KIT | DYB | DYB | TERUMO MEDICAL CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | SNARE RETRIEVAL DEVICE |