FDA Adverse Event
Other
Summary report: N
SYNTEL EMBOLECTOMY CATHETER, 3F, 80CM
MDR report key: 1654395
·
Received April 6, 2010
Report
- Report Number
- 2027111-2010-00052
- Event Type
- Other
- Date Received
- April 6, 2010
- Date of Event
- February 10, 2010
- Report Date
- April 6, 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, FOLLOW UP 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." "THE POPLITEAL ARTERY WAS OPENED SURGICALLY TO REMOVE THE MISSING TIP. ANGIOGRAM WAS THEN COMPLETED AND NO DAMAGE TO THE VESSEL WAS NOTED."
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 |