FDA Adverse Event
Injury
Summary report: N
INQUIRY FIXED CATHETER 6F, 1010-6-28-SC1-L(60)
MDR report key: 1830893
·
Received September 7, 2010
Report
- Report Number
- 2030404-2010-00121
- Event Type
- Injury
- Date Received
- September 7, 2010
- Date of Event
- August 9, 2010
- Report Date
- August 9, 2010
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- DRF
- PMA / PMN Number
- K946333
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED DISSECTION REMAINS UNK. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS POSITIONED IN THE CORONARY SINUS AND A DISSECTION OCCURRED. THE PT REQUIRED A PERICARDIOCENTESIS AND RECOVERED WITHOUT FURTHER CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INQUIRY FIXED CATHETER 6F, 1010-6-28-SC1-L(60) | NONE | DRF | ST. JUDE MEDICAL, IRVINE | 80940 | K27429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |