FDA Adverse Event
Other
Summary report: N
SYNTEL EMBOLECTOMY CATHETER, 3F, 80CM
MDR report key: 1635503
·
Received March 16, 2010
Report
- Report Number
- 2027111-2010-00032
- Event Type
- Other
- Date Received
- March 16, 2010
- Date of Event
- March 8, 2010
- Report Date
- March 17, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- DXE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS ANTICIPATED TO RETURN FOR EVAL. FOLLOW UP WILL BE PROVIDED.
Description of Event or Problem · 1
THROMBECTOMY W/ANGIOPLASTY - "ATTEMPTED TO PLACE EMBOLECTOMY CATHETER DOWN ARTERY AND CATHETER STUCK AT THE ANASTOMOSIS. WHILE ATTEMPTING TO REMOVE TIP OF EMBOLECTOMY CATHETER BROKE OFF AND STAYED IN PT. LATER WAS REMOVED WITH SNARE DEVICE. THE SECOND EMBOLECTOMY CATHETER WAS PLACED DOWN THE ARTERY AND WHILE ATTEMPTING TO PULL THE CATHETER TOWARDS THE SHEATH, THE EMBOLECTOMY CATHETER BALLOON BROKE OPEN. A THIRD CATHETER WAS USED TO COMPLETE THE CASE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTEL EMBOLECTOMY CATHETER, 3F, 80CM | EMBOLECTOMY CATHETER | DXE | APPLIED MEDICAL RESOURCES | A4F03 | 1101594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |