FDA Adverse Event
Other
Summary report: N
SYNTEL EMBOLECTOMY CATHETER, 3F, 80CM
MDR report key: 1649737
·
Received March 23, 2010
Report
- Report Number
- 2027111-2010-00043
- Event Type
- Other
- Date Received
- March 23, 2010
- Date of Event
- February 20, 2010
- Report Date
- March 17, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- DXE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ANTICIPATED TO RETURN, F/U WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
EMBOLECTOMY - "THE BALLOON BURST WHEN RETRIEVED THEN A SLIGHT CATCH WAS FELT. ON REMOVAL, THE TIP WAS NOTICED TO BE MISSING. THE VESSEL WAS THEN OPENED SURGICALLY TO REMOVE THE TIP AND IT WAS NOTICED THAT THE METAL SPRING WAS UNRAVELLED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTEL EMBOLECTOMY CATHETER, 3F, 80CM | EMBOLECTOMY CATHETER | DXE | APPLIED MEDICAL RESOURCES | A4F03 | 1092471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |