FDA Adverse Event
Injury
Summary report: N
SCOOP CATHETER
MDR report key: 2627367
·
Received September 21, 2009
Report
- Report Number
- 1721097-2009-00001
- Event Type
- Injury
- Date Received
- September 21, 2009
- Date of Event
- August 21, 2009
- Report Date
- September 21, 2009
- Manufacturer
- TRANSTRACHEAL SYSTEMS, INC.
- Product Code
- BTR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INCIDENT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
IN (B)(6) 2009, THE PT NOTICED BLOOD-TINGED MUCUS WHEN CLEANING TRACHEAL CATHETER. PT'S PHYSICIAN PERFORMED A BRONCHOSCOPY AND INFORMED PT THAT EVERYTHING WAS FINE. AT ABOUT 10 PM ON (B)(6) 2009, PT WAS TAKEN TO HOSPITAL WITH PROFUSE BLEEDING. PT DESCRIBED THE SITUATION AS A POSSIBLE RUPTURED AORTA, HOWEVER SUBSEQUENT RESEARCH PROVED IT TO BE A POSSIBLE PERFORATED INNOMINATE ARTERY. PT WAS TAKEN TO SURGERY WHERE THE PERFORATION WAS SUCCESSFULLY REPAIRED. PT HAS SINCE BEEN DISCHARGED FROM HOSPITAL AND IS AT HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCOOP CATHETER | NONE | BTR | TRANSTRACHEAL SYSTEMS, INC. | SCOOP CATHETER | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |